FDA Adverse Event
Injury
Summary report: N
TRIATHLON CEMENTED PS FEMORAL COMPONENT #2 RIGHT
MDR report key: 1790007
·
Received August 2, 2010
Report
- Report Number
- 9610726-2010-00242
- Event Type
- Injury
- Date Received
- August 2, 2010
- Date of Event
- July 5, 2010
- Report Date
- July 16, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K042993
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 5520-B-200 LOT# STA6T, DESCRIPTION: TRIATHLON-PRIM TIB BASEPLATE CEMENTED #2; CAT# 5532-P-209 LOT# LBT961, DESCRIPTION: TRIATHLON-PS TIBIAL INSERT #2 - 9 MM. 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, "THE PT HAD A INFECTION AFTER TKA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON CEMENTED PS FEMORAL COMPONENT #2 RIGHT | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SSECJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |