FDA Adverse Event
Injury
Summary report: N
CROSSFIRE 0 DEG INSERT
MDR report key: 1132047
·
Received August 21, 2008
Report
- Report Number
- 2249697-2008-00232
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 30, 2008
- Report Date
- July 30, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LZO
- PMA / PMN Number
- K974685
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADD'L INFO A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT "THE ARTHROPLASTY WAS REVISED DUE TO CERAMIC HEAD FRACTURE. THE ACETABULAR LINER AND FEMORAL HEAD WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 8.03 Y. THE PT PRESENTED A UCLA SCORE OF 7 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM UCLA SCORE OF 7 SINCE IMPLANTATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CROSSFIRE 0 DEG INSERT | IMPLANT | LZO | STRYKER ORTHOPAEDICS MAHWAH | NA | 1SVJS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |