FDA Adverse Event
Injury
Summary report: N
PFC SIG RPF INS SZ 3 10MM
MDR report key: 1842526
·
Received September 17, 2010
Report
- Report Number
- 1818910-2010-06237
- Event Type
- Injury
- Date Received
- September 17, 2010
- Date of Event
- August 19, 2010
- Report Date
- August 19, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- NJL
- PMA / PMN Number
- P830055/S113
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE REPORT STATES: THE PATIENT WAS REVISED TO ADDRESS A FAILED KNEE REVISION. OSTEOLYSIS, POLYWEAR OF THE TIBIAL INSERT, AND LOOSENING OF THE TIBIA AND FEMUR WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIG RPF INS SZ 3 10MM | 87NJL | NJL | DEPUY ORTHOPAEDICS, INC. | NA | BF0228361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |