FDA Adverse Event
Injury
Summary report: N
TRIDENT 0 CROSSFIRE INSERT 32 MM ID
MDR report key: 2134875
·
Received June 15, 2011
Report
- Report Number
- 9616680-2011-00401
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 30, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K983382
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PT HAD A THA BY A ROBODOC (BLADE: MIDAS REX) IN 2006. THE SURGEON PERFORMED A REVISION THA DUE TO AN OSTEOLYSIS OF THE CENTPILLAR STEM ON (B)(6). THE SURGEON NOTICED A LOT OF METAL POWDER ON THE SLIDING SURFACE OF THE INSERT AND A LOT OF SCRATCHES ON THE HEAD. THE SURGEON WOULD LIKE TO KNOW WHERE THE METAL POWDER CAME FROM, STEM OR CUP OR HEAD OR MIDAS REX BLADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 0 CROSSFIRE INSERT 32 MM ID | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 16264701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |