FDA Adverse Event Other Summary report: N

CR CEMENTED 3 PCG PATELLA

MDR report key: 638800 · Received September 30, 2005

Report

Report Number
1038671-2005-00047
Event Type
Other
Date Received
September 30, 2005
Date of Event
July 14, 2005
Report Date
September 30, 2005
Manufacturer
EXACTECH
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
OK, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

HOSPITAL REPORTED "THIS PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY IN SEPTEMBER 2002. THEY HAVE CONTINUED TO HAVE PROBLEMS WITH STABILITY AND BALANCE AND HAVE BEEN USING A BRACE." IMPLANTS WERE NOT INDICATED AS CAUSE OF INSTABILITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CR CEMENTED 3 PCG PATELLA PATELLA COMPONENT JWH EXACTECH * *

Patients

Seq Age Sex Outcome Treatment
1 76 YR Hospitalization| R