FDA Adverse Event
Injury
Summary report: N
TRIATHLON-CR FEMORAL COMPONENT CEMENTED #8 LEFT
MDR report key: 2202587
·
Received August 8, 2011
Report
- Report Number
- 9610726-2011-00287
- Event Type
- Injury
- Date Received
- August 8, 2011
- Date of Event
- July 28, 2011
- Report Date
- July 28, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K040267
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 5520-B-800, LOT # 5X69Y DESCRIPTION: TRIATHLON-PRIM TIB BASEPLATE CEMENTED #8. CAT # 5530-G-813, LOT# 15MM DESCRIPTION: TRIATHLON CR X3 TIBIAL INSERT. CAT # 5551-G-381, LOT# A552 DESCRIPTION: TRIATHLON ASYMMETRIC X3 PATELLA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "ALL REMOVED DUE TO INFECTIONS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-CR FEMORAL COMPONENT CEMENTED #8 LEFT | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SJ8JN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |