[Survey of incidents associated with hip and knee replacement devices. Analysis of the surveillance and registration system for medical products for the years 2000-2002].
BACKGROUND
The purpose of this study was to address the experience gained from the risk assessment of incidents associated with hip and knee joint replacement devices.


METHODS
A total of 274 incidents were reported throughout the years 2000-2002. A retrospective survey of all reports was conducted.


RESULTS
Of all cases, 85.0% were associated with reported patient injury (n=274). In 88.4% of these cases injury consisted in revision surgery (n=233). Focusing on the cases alone where implant lifetime was known, 42.6% of these incidents occurred within the 1st year and 87.9% within 5 years (n=148). Only 20.4% of all incidents were caused by a production error (n=274); 36.2% of all incidents directly led to corrective action (n=274). In 10.2% the incident occurred at a time when corrective action had already been taken (n=274); this corresponds to 23.0% of all patients involved in incidents (n=291).


CONCLUSIONS
In general, improvements in implant design during the past decade have increased the level of protection of health and safety of hip and knee joint replacement devices. Nevertheless, our data suggest that there is still a certain amount of design problems contributing to implant failure. By increasing the number of reports, users could help to enhance the safety of these devices.
Heinz
B C
BC
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn. bheinz@bfarm.de
von Mallek
D
D
D005858:Germany / Q000453:epidemiology; D019538:Health Care Surveys; D006622:Hip Prosthesis / Q000706:statistics & numerical data*; D006801:Humans; D015994:Incidence; D007720:Knee Prosthesis / Q000706:statistics & numerical data*; D019221:Mandatory Reporting; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000706:statistics & numerical data*; D011475:Prosthesis Failure; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors