FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 56M
MDR report key: 1030066
·
Received April 15, 2008
Report
- Report Number
- 9616680-2008-00091
- Event Type
- Injury
- Date Received
- April 15, 2008
- Date of Event
- March 18, 2008
- Report Date
- March 18, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NEITHER THE DEVICE NOR ADD'L INFO HAS BEEN MADE AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THIS TRIDENT HEMISPHERICAL CUP WAS IMPLANTED OVER A YR AGO. X-RAYS TAKEN LAST MONTH INDICATED A CHANGE IN CUP POSITION. CUP WAS REVISED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 56M | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 19186801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |