FDA Adverse Event
Injury
Summary report: N
TRIDENT ALUMINA INSERT
MDR report key: 1962693
·
Received January 10, 2011
Report
- Report Number
- 9616680-2011-00020
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 28, 2010
- Report Date
- December 28, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- P000013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT REPORTED SEVERAL INCIDENCES OF FEELING AS IF HER HIP WAS LOCKED UPON ATTEMPTING TO AMBULATE AFTER PROLONGED PERIODS OF REST. SHE ALSO REPORTED PAIN WHEN THIS OCCURRED. SURGEON ELECTED TO REVISE THE PT'S HIP AND CONVERT IT TO A CERAMIC ON POLYETHYLENE BEARING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT ALUMINA INSERT | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 31308302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |