FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 60MM
MDR report key: 2202438
·
Received August 5, 2011
Report
- Report Number
- 9616680-2011-00522
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 19, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "CUP WAS LOOSE AND SQUEAKING COULD BE HEARD. REPLACED WITH V40/C-TAPER ADAPTER SLEEVE AND 36MM +5 BIOLOX C-TAPER HEAD. USED ZIMMER CUP AND LINER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 60MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 12073501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |