FDA Adverse Event
Injury
Summary report: N
TRIATHLON-PRIM TIB BASEPLATE CEMENTED #2
MDR report key: 1962695
·
Received January 10, 2011
Report
- Report Number
- 9610726-2011-00005
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 27, 2010
- Report Date
- December 28, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K031729
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "PT WAS REVISED DUE TO A FAILED KNEE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-PRIM TIB BASEPLATE CEMENTED #2 | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SPMTB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |