FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 12
MDR report key: 2896252
·
Received December 28, 2012
Report
- Report Number
- 2249697-2012-02823
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- December 11, 2012
- Report Date
- December 11, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K071082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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, DOCTOR REVISED PT'S RIGHT HIP DUE TO ALTR SERUM LEVELS, COBALT 13, CHROME 2.5. JOINT FLUID ASPIRATE DRAWN BUT LAB RESULTS NOT AVAILABLE AT DATE OF SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 12 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | 6EXMMDX1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other| R |