FDA Adverse Event
Injury
Summary report: N
KRH DURATION BUSHING STANDARD1
MDR report key: 1936995
·
Received December 16, 2010
Report
- Report Number
- 9610726-2010-00477
- Event Type
- Injury
- Date Received
- December 16, 2010
- Date of Event
- December 2, 2010
- Report Date
- December 3, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K972863
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- 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: KRH DURATION STANDARD BUMPER, CAT# 6485-4-100, LOT# LPTB856. KRH STANDARD AXLE, CAT# 6475-3-940, LOT# UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REVISED BUMPER ON (B)(6) 2010. SURGEON DID NOT WANT TO REVISE BUSHINGS AT THAT TIME. PATIENT WAS WALKING RECENTLY AND HER KNEE GAVE OUT. DID REVISION TODAY AND EXCHANGED THE BUSHINGS, AXLE AND BUMPER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KRH DURATION BUSHING STANDARD1 | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |