FDA Adverse Event
Injury
Summary report: N
PFC MOD DOME PATELLA 35MM
MDR report key: 626067
·
Received August 10, 2005
Report
- Report Number
- 1818910-2005-01375
- Event Type
- Injury
- Date Received
- August 10, 2005
- Date of Event
- May 8, 2005
- Report Date
- July 26, 2005
- Manufacturer
- DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
SUIT WAS FILED. PT RECEIVED BILATERAL KNEES IN 1995. SUIT PAPERS CLAIM THEY FAILED AFTER 8 YEARS DUE TO PREMATURE DETERIORATION OF THE PRODUCT. LEFT KNEE WAS REVISED IN 2003 AND THE RIGHT WILL TAKE PLACE IN THE NEAR FUTURE. THE RIGHT KNEE WAS REVISED IN 2005 BY A DOCTOR AT HOSPITAL. THE PART/LOT NUMBER FOR THE RIGHT KNEE REVISION IS: 86-6061, LOT: 012978. IN 2005 RECEIVED OP NOTES WHICH INDICATE THAT THE RIGHT KNEE PATELLA WAS FOUND IN MULTIPLE PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC MOD DOME PATELLA 35MM | TOTAL KNEE PROSTHESIS | JWH | DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. | NA | C468 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |