FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 50MM
MDR report key: 1012649
·
Received March 11, 2008
Report
- Report Number
- 9616680-2008-00060
- Event Type
- Injury
- Date Received
- March 11, 2008
- Date of Event
- February 11, 2008
- Report Date
- February 11, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS SENT BY THE REPORTER TO A THIRD PARTY FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT'S COMPLETE RIGHT HIP WAS REVISED. PATIENT HAD PRIMARY HIP SURGERY IN 2005. THREE MONTHS POST OP SHOWED THEM DOING WELL, WITH NO PAIN. AT NINE MONTHS POST OP, HAD SOME DISCOMFORT, BUT NO ABNORMALITIES. BY TWO YEARS POST OP, THERE WAS INCREASED PAIN, AND AP FILMS SHOW LOOSENING OF ACETABULAR COMPONENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 50MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 1232701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |