FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL HA CLUSTER 58MM
MDR report key: 1822790
·
Received August 30, 2010
Report
- Report Number
- 9616680-2010-00530
- Event Type
- Injury
- Date Received
- August 30, 2010
- Date of Event
- August 16, 2010
- Report Date
- August 16, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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
BOOKED AS REVISION OF TRIDENT ACETABULUM FOR ASEPTIC LOOSENING 4 YRS POST INDEX PROCEDURE. REVISION OF TRIDENT C ON C CUP AND LINER 4 YRS POST INDEX PROCEDURE. THIS CUP WAS SHOWN (BY BONE SCAN) TO BE WELL FIXED 2 YRS POST OP. THE PT DENIES A FALL BUT DID STATE THAT SHE HAD A "SLIP" PRIOR TO THE ONSET OF SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 58MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 18192101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |