FDA Adverse Event
Injury
Summary report: N
TRIDENT ALUMINA INSERT
MDR report key: 2232476
·
Received August 25, 2011
Report
- Report Number
- 9616680-2011-00549
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- August 2, 2011
- Report Date
- August 2, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MRA
- PMA / PMN Number
- P000013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT HAD BEEN COMPLAINING OF PAIN AND HAD HAD A RELEASE ILIPSOAS TENDON (B)(6)-2011. PT STILL HAD PAIN AND SURGEON SUSPECTED LOOSENING. UPON SURGICAL INSPECTION NO COMPONENTS WERE LOOSE, BEARING SURFACES LOOKED GOOD AND WILL BE RETURNED. NO DECONTAMINATED FOR BIOLOGICAL EXAMINATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT ALUMINA INSERT | IMPLANT | MRA | STRYKER ORTHOPAEDICS CORK | NA | 26991301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |