FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI NCK 8DEG 30MM
MDR report key: 2885253
·
Received December 18, 2012
Report
- Report Number
- 9616680-2012-01433
- Event Type
- Injury
- Date Received
- December 18, 2012
- Date of Event
- December 2, 2012
- Report Date
- December 2, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K071082
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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, DR (B)(6) STATES PATIENT PRESENTED WITH INCREASED PAIN IN JOINT AREA, ELEVATED CHROME AND COBALT SERUM LEVELS, POSITIVE MARS SCAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG TAP PRI NCK 8DEG 30MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 27503902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |