FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 30MM
MDR report key: 2901585
·
Received January 3, 2013
Report
- Report Number
- 9616680-2012-01540
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 10, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K071082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT SURGEON REVISED PT'S RIGHT REJUVENATE HIP, DUE TO PAIN AND ELEVATED COBALT LEVELS. REPLACED WITH EXETER SYSTEM. SALES REP WILL PROVIDE X-RAYS, PRE AND POST OP NOTES, LAB REPORT AND IMPLANT SHEETS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2122 | LRG TAP PRI MOD NCK 0DEG 30MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | 35368002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other| R |