FDA Adverse Event
Injury
Summary report: N
ACETABULAR CUP CROSSFIRE
MDR report key: 2042102
·
Received March 30, 2011
Report
- Report Number
- 9616680-2011-00158
- Event Type
- Injury
- Date Received
- March 30, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 17, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LPH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PT HAD A THA ON (B)(6), 2011. THREE WEEKS LATER, THE CUP COME OUT FROM THE PT'S ACETABULI ALONG WITH THE SIMPLEX P. THE SURGEON IS PLANNING A REVISION SURGERY ON (B)(6) 2011."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACETABULAR CUP CROSSFIRE | IMPLANT | LPH | STRYKER ORTHOPAEDICS CORK | NA | 14VDY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |