FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 48 MM
MDR report key: 1120875
·
Received August 15, 2008
Report
- Report Number
- 9616680-2008-00245
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- July 29, 2008
- Report Date
- July 29, 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
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT WAS ON SCHEDULE TO SEE SURGEON FOR HIP DISCOMFORT. PRIOR TO APPT. SHE FELL COMPLETELY DISLODGING ACETABULAR COMPONENT. THE ONE SCREW IMPLANTED IS SHEARED ON X-RAY, ORIGINAL SURGERY PERFORMED IN 2007. SURGEON'S OPERATIVE REPORT STATES THE SURGERY WAS NEEDED DUE TO FAILED PRIMARY SURGERY. SURGEON IN HIS REVISION WAS ABLE TO REMOVE THE IMPLANTED SHELL EASILY AND REIMPLANTED A DEPUY PROD. PT'S STRYKER ACCOLADE TMZF (SIZE 1) WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 48 MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |