FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 8 DEG 30MM
MDR report key: 2896008
·
Received December 27, 2012
Report
- Report Number
- 9616680-2012-01497
- Event Type
- Injury
- Date Received
- December 27, 2012
- Date of Event
- October 31, 2012
- Report Date
- December 6, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K071082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE HIP PAIN AND WAS FOUND TO HAVE ELEVATED COBALT CHROMIUM LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG TAP PRI MOD NCK 8 DEG 30MM | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | 32356901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |