FDA Adverse Event
Injury
Summary report: N
KRH DURATION BUSHING STANDARD
MDR report key: 2757063
·
Received September 19, 2012
Report
- Report Number
- 9610726-2012-00303
- Event Type
- Injury
- Date Received
- September 19, 2012
- Date of Event
- August 31, 2012
- Report Date
- August 31, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K972863
- 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 DISCARDED UPON REMOVAL. SHOULD ADD¿L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT. CAT # 6485-2-460, LOT # TCPC905. DESCRIPTION: KRH DURATION BUSHING STANDARD. CAT # 6485-4-100, LOT# TCPC440, DESCRIPTION: KRH DURATION STANDARD BUMPER. 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 THE PT HAS INFECTION, EXCHANGED THE BUSHINGS AND BUMPER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KRH DURATION BUSHING STANDARD | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | XVCXA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |