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 |