FDA Adverse Event
Injury
Summary report: N
TRIDENT AD ACETABULUAR SHELL 54MM SIZE
MDR report key: 1873604
·
Received October 12, 2010
Report
- Report Number
- 9616680-2010-00630
- Event Type
- Injury
- Date Received
- October 12, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 21, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LPH
- PMA / PMN Number
- K983502
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE SURGEON PERFORMED A REVISION SURGERY TO REPLACE A CUP, SCREWS, INSERT AND HEAD ON THE PATIENT DUE TO A CUP LOOSENING (OSTEOLYSIS).".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT AD ACETABULUAR SHELL 54MM SIZE | IMPLANT | LPH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |