FDA Adverse Event
Injury
Summary report: N
ABC ALUMINA C-TAPER HEAD
MDR report key: 500012
·
Received December 8, 2003
Report
- Report Number
- 9616680-2003-00042
- Event Type
- Injury
- Date Received
- December 8, 2003
- Report Date
- November 11, 2003
- Manufacturer
- STRYKER HOWMEDICA OSTEONICS
- Product Code
- MRA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISLOCATIONS IN 04/2003. DUE TO INSTABILITY OF THE HIP, THE PATIENT HAD A REVISION EIGHTEEN DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABC ALUMINA C-TAPER HEAD | IMPLANT | MRA | STRYKER HOWMEDICA OSTEONICS | NA | 23571001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |