FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 54MM
MDR report key: 1053358
·
Received May 28, 2008
Report
- Report Number
- 9616680-2008-00131
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- April 11, 2008
- Report Date
- May 1, 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
IT CANNOT BE CONFIRMED THAT ANY DEVICE MANUFACTURED BY STRYKER MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT PRESENTED WITH GROIN PAIN, WAS CULTURED AND INFECTION WAS THE DIAGNOSIS. SURGEON TOOK PATIENT TO SURGERY, REMOVED CUP AND REPLACED IT WITH A 54MM BIPOLAR SHELL. THE SURGEON OBSERVED UPON CUP REMOVAL THAT THE ACETABULAR WAS QUITE SCLEROTIC."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 54MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 21907501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |