FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 52MM
MDR report key: 1113185
·
Received August 12, 2008
Report
- Report Number
- 9616680-2008-00242
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 25, 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
- NM, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT "PRODUCT WAS IMPLANTED APPROXIMATELY ONE YEAR AGO, PATIENT WAS DOING FINE, UNTIL ABOUT TWO MONTHS AGO, PATIENT PRESENTED TO DOCTORS OFFICE COMPLAINING OF PAIN, AT WHICH POINT XRAY SHOWED RADIOLUCENCIES APPEARED ON THE ACETABULAR SHELL. PATIENT WAS SCHEDULED FOR REVISION, AND AT REVISION IT WAS CONFIRMED THAT CUP WAS INDEED LOOSE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 52MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 19852801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |