FDA Adverse Event
Injury
Summary report: N
TRIATHLON-PRIM TIB BASEPLATE USAE MOLD #1434
MDR report key: 1982220
·
Received January 24, 2011
Report
- Report Number
- 9610726-2011-00015
- Event Type
- Injury
- Date Received
- January 24, 2011
- Date of Event
- December 31, 2010
- Report Date
- December 31, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K040267
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2011-00084.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT WAS BROUGHT TO OPERATING ROOM TO REVISE A LOOSE TOTAL KNEE. FEMUR AND TIBIA WERE FOUND TO BE LOOSE AND WERE REVISED WITH TRIATHLON PRIMARY IMPLANTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-PRIM TIB BASEPLATE USAE MOLD #1434 | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SPC6X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |