FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 30MM
MDR report key: 2901609
·
Received January 3, 2013
Report
- Report Number
- 9616680-2012-01543
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- May 6, 2010
- Report Date
- December 7, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K092561
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: MECHANICALLY ASSISTED CREVICE CORROSION AND SECONDARY ADVERSE LOCAL SOFT TISSUE REACTION WITH PSEUDOTUMOR FORMATION AFTER REJUVENATE FEMORAL COMPONENT DUE TO MODULAR NECK - STEM MECHANISM OF FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3265 | LRG TAP PRI MOD NCK 0DEG 30MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 39683101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other| R |