FDA Adverse Event
Injury
Summary report: N
NRG KNEE P/S NRG BEARING INSERT S
MDR report key: 1892114
·
Received November 3, 2010
Report
- Report Number
- 9616680-2010-00702
- Event Type
- Injury
- Date Received
- November 3, 2010
- Date of Event
- October 18, 2010
- Report Date
- October 19, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JWH
- PMA / PMN Number
- K030978
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REVISION DUE TO PATIENT'S KNEE WAS VERY FLOPPY AND WHEN GOT IN THERE, THE POST ON THE TIBIAL INSERT WAS DISASSOCIATED. LOCATED THE POST AS WELL AND REMOVED."
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 | 19657601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |