FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 58MM
MDR report key: 1160472
·
Received September 12, 2008
Report
- Report Number
- 9616680-2008-00279
- Event Type
- Injury
- Date Received
- September 12, 2008
- Date of Event
- April 16, 2008
- Report Date
- August 28, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. DEVICES WERE DISCARDED IMMEDIATELY AFTER SURGERY. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS ADMITTED FOR HIP REVISION SURGERY DUE TO WORN CUP AND MALPOSITIONED ACETABULAR SHELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 58MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 5872201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |