Increasing patient safety and orthopaedic device quality via adverse event reporting mechanisms

Journal of Bone and Joint Surgery

Volumn 86, Issue SUPPL. 2, 2004, Pages 33-34

  Tanner, Michael ^a   Bradley, Gloria ^b  

^a Barnum Center   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; DEATH; FOOD AND DRUG ADMINISTRATION; HUMAN; IMPLANT; MATERIALS; ORTHOPEDIC EQUIPMENT; PATIENT CARE; PRIORITY JOURNAL; QUALITY CONTROL; SAFETY;

EID: 10344265948     PISSN: 00219355     EISSN: None     Source Type: Journal    
DOI: 10.2106/00004623-200412002-00006     Document Type: Conference Paper

References (5)

1. Hirakawa K, Jacobs JJ, Urban R, Saito T. Mechanisms of failure of total hip replacements: lessons learned from retrieval studies. Clin Orthop. 2004;420:10-7.
2. Department of Health and Human Services, Food and Drug Administration. Medical devices: medical device user facility and manufacturer reporting, certification and registration. Fed Regist. 1995;60:63577-606.
3. Castro FP Jr, Chimento G, Munn BG, Levy RS, Timon S, Barrack RL. An analysis of Food and Drug Administration medical device reports relating to total joint components. J Arthroplasty. 1997;12:765-71.
4. Engh GA, Wolf R. Responsibilities when confronting a defective surgical implant. Clin Orthop. 2003;407:54-8.
5. Sulzer warns about insurance for implants. Austin Business Journal 2001 May 21. www.bizjournals.com/austin/stories/2001/05/21/daily18.html.