FDA Adverse Event
Injury
Summary report: N
NRG KNEE P/S NRG BEARING INSERT S
MDR report key: 2071017
·
Received April 20, 2011
Report
- Report Number
- 9616680-2011-00234
- Event Type
- Injury
- Date Received
- April 20, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JWH
- PMA / PMN Number
- K030978
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A REVISION SURGERY TO EXPLANT ALL COMPONENTS (FEMORAL, TIBIAL AND INSERT) DUE TO A LOOSENING ON (B)(6) 2011. HE REMOVED THEM AND IMPLANTED SOME CEMENTS MOLDS. THE SURGEON REQUESTED A WEAR ANALYSIS REPORT ON THE REPORTED INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NRG KNEE P/S NRG BEARING INSERT S | IMPLANT | JWH | STRYKER ORTHOPAEDICS CORK | NA | 21724201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |