FDA Adverse Event
Injury
Summary report: N
MRHK TIB INS 20MM XS/S S1/S2
MDR report key: 2857931
·
Received November 19, 2012
Report
- Report Number
- 9610726-2012-00362
- Event Type
- Injury
- Date Received
- November 19, 2012
- Date of Event
- November 5, 2012
- Report Date
- November 5, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- KRO
- PMA / PMN Number
- K994207
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 6481-2-140, LOT# UNK. DESCRIPTION: MRHK TIBIAL SLEEVE. CAT# 6485-2-465, LOT# UNK. DESCRIPTION: KRH DURATION BUSHING SML. CAT# 6485-4-100. LOT# UNK. DESCRIPTION: KRH DURATION STANDARD BUMPER. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, DR. (B)(6) DID AN I AND D AND POLY EXCHANGE OF THE ABOVE COMPONENTS DUE TO AN INFECTION ON THE PATIENTS KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRHK TIB INS 20MM XS/S S1/S2 | IMPLANT | KRO | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |