FDA Adverse Event
Malfunction
Summary report: N
TRIATHLON-CR FEMORAL COMPONENT CEMENTED #4 LEFT
MDR report key: 2000029
·
Received February 3, 2011
Report
- Report Number
- 9610726-2011-00024
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- January 17, 2011
- Report Date
- January 17, 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
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DOCTOR APPROVED OPENING THE #4 CR LEFT CEMENTED FEMORAL COMPONENT. UPON BACK TABLE PREPARATION AND APPLICATION OF CEMENT BY SCRUB TECH, IT WAS NOTICED THAT A RED RESIDUE WAS ON THE BACK SIDE OF THE FEMORAL COMPONENT. AT THAT POINT ANOTHER CR #4 LEFT FEMUR WAS BROUGHT INTO THE ROOM TO BE OPENED AND IMPLANTED. AFTER THE CASE, SALES REP TOOK THE IMPLANT WITH THE RESIDUE AND CLEANED IT WITH HOT WATER AND A CLEANING AGENT ENZYME TO WASH AWAY A LITTLE BLOOD THAT WAS ON THE IMPLANT. THE CLEANING PROCEDURE ALSO WASHED AWAY THE RESIDUE.
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 | SYAJK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |