FDA Adverse Event
Injury
Summary report: N
TRIATHLON-CR FEMORAL COMPONENT CEMENTED #5 RIGHT
MDR report key: 1884408
·
Received October 21, 2010
Report
- Report Number
- 9610726-2010-00379
- Event Type
- Injury
- Date Received
- October 21, 2010
- Date of Event
- September 2, 2009
- Report Date
- October 6, 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
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 5551-L-350, LOT# LBO624, DESCRIPTION: TRIATHLON-ASYMMETRIC PATELLA A35MM (S/I) X 10MM. CAT# 5530-P-509, LOT# LBN277, DESCRIPTION: TRIATHLON-CR TIBIAL INSERT #5-9MM. CAT# 5520-B-500, LOT# SKH3B, DESCRIPTION: TRIATHLON-PRIM TIB BASEPLATE USAE MOLD # 1434. 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, "INFECTION KNEE. E-COL".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-CR FEMORAL COMPONENT CEMENTED #5 RIGHT | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SL37M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |