FDA Adverse Event
Malfunction
Summary report: N
TRIATHLON-CR FEMORAL COMPONENT CEMENTED #4 LEFT
MDR report key: 2062566
·
Received April 7, 2011
Report
- Report Number
- 9610726-2011-00100
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 21, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K040267
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE UNIT WAS OPENED, THE TWO PLASTIC CASINGS SEEMED TO BE MELTED TOGETHER. IT WAS REPORTED THAT THE ACCOUNT HAD USE A NEW COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-CR FEMORAL COMPONENT CEMENTED #4 LEFT | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SX3FC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |