FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 60MM
MDR report key: 1132048
·
Received August 21, 2008
Report
- Report Number
- 9616680-2008-00247
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 28, 2008
- Report Date
- July 28, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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. ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 9616680-2008-00248.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT'S HIP WAS REVISED IN 2008. SURGEON STATED THAT THE STEM AND CUP WERE LOOSE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 60MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |