Perspectives in managing an implant recall: Revision of 94 durom metasul acetabular components

Journal of Bone and Joint Surgery

Volumn 93, Issue 17, 2011, Pages

  Ng, Vincent Y ^a   Arnott, Lindsay ^b   McShane, Michael A ^b  

^a THE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER   (United States)

^b Ohio Orthopedic Center of Excellence   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETABULUM; BONE SCINTISCANNING; COMPUTER ASSISTED TOMOGRAPHY; DEVICE RECALL; FOLLOW UP; HUMAN; PHYSICAL EXAMINATION; PRIORITY JOURNAL; PROSTHESIS FAILURE; REVIEW; TENDINITIS; TOTAL HIP PROSTHESIS;

EID: 80052888595     PISSN: 00219355     EISSN: 15351386     Source Type: Journal    
DOI: 10.2106/JBJS.J.01311     Document Type: Review

References (44)

1. Statement by Zimmer Holdings, Inc. 2008 Jul 29. http://www.zimmer.com/z/ ctl/op/global/action/1/id/10126/template/MP. Accessed 2011 Jun 11.
2. Long WT, Dastane M, Harris MJ, Wan Z, Dorr LD. Failure of the Durom Metasul acetabular component. Clin Orthop Relat Res. 2010;468:400-5.
3. Vendittoli P, Mottard S, Roy AG, Dupont C, Lavigne M. Chromium and cobalt ion release following the Durom high carbon content, forged metal-on-metal surface replacement of the hip. J Bone Joint Surg Br. 2007;89:441-8. (Pubitemid 46851121)
4. Kärrholm J, Garellick G, Herberts P. Annual report 2006: Swedish hip arthroplasty register. 2007. http://www.jru.orthop.gu.se/. Accessed 2009 Oct 20.
5. Davies AP, Willert HG, Campbell PA, Learmonth ID, Case CP. An unusual lymphocytic perivascular infiltration in tissues around contemporary metal-on-metal joint replacements. J Bone Joint Surg Am. 2005;87:18-27. (Pubitemid 40094135)
6. FDA. MAUDE adverse event report: Zimmer GMBH Durom US acetabular component 48/42 H Durom Acetabular Component and Metasul LDH LA. 2008 May 19. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi-id= 1065931. Accessed 2010 Jul 14.
7. Maglio Christopher Toale Law Firm. Problems with loose Zimmer Durom hip joint replacement cups. 2008. http://www.mctplaw.com/joint-replacement/zimmer- durom.php. Accessed 2010 Dec 27.
8. Berton C, Girard J, Krantz N, Migaud H. The Durom large diameter head acetabular component: early results with a large-diameter metal-on-metal bearing. J Bone Joint Surg Br. 2010;92:202-8.
9. Illgen RL 2nd, Heiner JP, Squire MW, Conrad DN. Large-head metal-on-metal total hip arthroplasty using the Durom acetabular component at minimum 1-year interval. J Arthroplasty. 2010;25(6 Suppl):26-30.
10. Izquierdo-Avino RJ, Siney PD, Wroblewski BM. Polyethylene wear in the Charnley offset bore acetabular cup. A radiological analysis. J Bone Joint Surg Br. 1996;78:82-4.
11. Pinnacle revision cup system design rationale. A new vision in revision acetabular reconstruction. DePuy. 2010. http://www.bizwan.com/depuy/hiptech/DPY- 0612-03-503r1-Pinnacle-Rev-Design-Rationale.pdf. Accessed 2010 Dec 27.
12. Blanchard CR, Zimmer, Warsaw, IN. Personal communication; 2008 May 29. http://www.zimmer.com/web/enUS/pdf/Zimmer-Durom-Surgeon-Letter-FINAL-May.pdf. Accessed 2010 Aug 23.
13. Blanchard CR, Zimmer, Warsaw, IN. Urgent device correction. 2008 Jul 22. http://www.zimmer.com/web/enUS/pdf/DUROM-SURGEON-LETTER-07-22-08-FINAL1.pdf. Accessed 2010 Aug 23.
14. Meier B. A call for a warning system on artificial joints. The New York Times. 2008 Jul 29. http://www.nytimes.com/2008/07/29/business/29hip.html. Accessed 2011 Jun 11.
15. FDA. Class 2 recall Durom cup. 2008 Sept 26. http://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72744. Accessed 2010 Jul 15.
16. Zimmer. Metasul LDH large diameter head with Durom acetabular component: surgical technique. Warsaw, IN: Zimmer; 2008.
17. Sen. Grassley questions Zimmer on product complaints, performance tracking. 2010 Aug 13. http://www.orthosupersite.com/view.aspx?rid=67111. Accessed 2011 Jun 10.
18. Zimmer statement regarding completion of Senate Finance Committee inquiry. Zimmer. 2011. http://www.zimmer.com/en-US/hcp/news/news-01-12-11- statementstate-finance-inquiry.jspx. Accessed 2011 Mar 17.
19. Engh GA, Wolf R. Responsibilities when confronting a defective surgical implant. Clin Orthop Relat Res. 2003;407:54-8. (Pubitemid 36176492)
20. Capozzi JD, Rhodes R. Managing medical errors. J Bone Joint Surg Am. 2009;91:2520-1.
21. Meier B. Insurers picking up recall cost. The New York Times. 2006 Feb 18. http://www.nytimes.com/2006/02/18/business/18device.html. Accessed 2010 Jul 15.
22. Bartels D. Disclosing risks of new technologies: ethical challenges for physicians, patients, and companies. Minnesota J Law Sci Technol. 2005;7:183-8.
23. Brenner LH, Bal BS. Expanding informed consent: what should orthopedic surgeons disclose to patients? 2008 Jun. http://www.orthosupersite.com/view. aspx?rid=28650. Accessed 2010 Oct 29.
24. Gelberman RH, Samson D, Mirza SK, Callaghan JJ, Pellegrini VD Jr. Orthopaedic surgeons and the medical device industry: the threat to scientific integrity and the public trust. J Bone Joint Surg Am. 2010;92:765-77.
25. Capozzi JD, Rhodes R, Chen D. Discussing treatment options. J Bone Joint Surg Am. 2009;91:740-2.
26. Holt G, Wheelan K, Gregori A. The ethical implications of recent innovations in knee arthroplasty. J Bone Joint Surg Am. 2006;88:226-9. (Pubitemid 43062793)
27. Huiskes R. Failed innovation in total hip replacement. Diagnosis and proposals for a cure. Acta Orthop Scand. 1993;64:699-716.
28. Huiskes R, Verdonschot NJ. Failure scenarios and the innovation cycle. In: Callaghan JJ, Rosenberg AG, Rubash HE, editors. The adult hip. Vol 1. Philadelphia: Lippincott Williams & Wilkins; 2007. p 167-83.
29. Suckel A, Geiger F, Kinzl L, Wulker N, Garbrecht M. Long-term results for the uncemented Zweymuller/Alloclassic hip endoprosthesis. A 15-year minimum followup of 320 hip operations. J Arthroplasty. 2009;24:846-53.
30. Bjørgul K, Novicoff WM, Andersen ST, Brevig K, Thu F, Wiig M, Ahlund O. The Charnley stem: clinical, radiological and survival data after 11-14 years. Orthop Traumatol Surg Res. 2010;96:97-103.
31. Clohisy JC, HarrisWH. The Harris-Galante porous-coated acetabular component with screw fixation. An average ten-year follow-up study. J Bone Joint Surg Am. 1999;81:66-73. (Pubitemid 29068449)
32. Zenz P, Stiehl JB, Knechtel H, Titzer-Hochmaier G, Schwagerl W. Ten-year followup of the non-porous Allofit cementless acetabular component. J Bone Joint Surg Br. 2009;91:1443-7.
33. Bjørgul K, Novicoff WM, Andersen ST, Brevig K, Thu F, Wiig M, Ahlund O. No differences in outcomes between cemented and uncemented acetabular components after 12-14 years: results from a randomized controlled trial comparing Duraloc with Charnley cups. J Orthop Traumatol. 2010;11:37-45.
34. Attarian DE, Vail TP. Medicolegal aspects of hip and knee arthroplasty. Clin Orthop Relat Res. 2005;433:72-6. (Pubitemid 40489250)
35. Crowninshield R. The orthopaedic profession and the orthopaedic industry: partners in quality patient care. J Bone Joint Surg Am. 2003;85:164. (Pubitemid 36537989)
36. Brenner LH, Bal BS. Doctor vs. device manufacturer: a case study in what not to do. Orthop Today. 2010;30:40-1.
37. Maisel WH. Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. JAMA. 2005;294:955-8. (Pubitemid 41215465)
38. Capozzi JD, Rhodes R. Examining the ethical implications of an orthopaedic joint registry. J Bone Joint Surg Am. 2010;92:1330-3.
39. Herberts P, Malchau H. Long-term registration has improved the quality of hip replacement: a review of the Swedish THR Register comparing 160,000 cases. Acta Orthop Scand. 2000;71:111-21. (Pubitemid 30611734)
40. Tanner M, Bradley G. Increasing patient safety and orthopaedic device quality via adverse event reporting mechanisms. J Bone Joint Surg Am. 2004;86 Suppl 2:33-4. (Pubitemid 39628345)
41. Fakler JK, Robinson Y, Heyde C, John T. Errors in handling and manufacturing of orthopaedic implants: the tip of the iceberg of an unrecognized system problem? Patient Saf Surg. 2007;1:5.
42. Craviotto DF Jr. Dissemination of information, among orthopaedic surgeons, regarding early failure of total joint implants. J Bone Joint Surg Am. 2001;83:1580-1. (Pubitemid 32953359)
43. Bono JV, Sanford L, Toussaint JT. Severe polyethylene wear in total hip arthroplasty. Observations from retrieved AML PLUS hip implants with an ACS polyethylene liner. J Arthroplasty. 1994;9:119-25. (Pubitemid 24125808)
44. DePuy ASR™ hip implant recall guide. DePuy. 2010. http://asrrecall.depuy.com/usprofessional. Accessed 2010 Oct 29.