FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 2981747
·
Received February 27, 2013
Report
- Report Number
- 0002249697-2013-00809
- Event Type
- Injury
- Date Received
- February 27, 2013
- Date of Event
- February 5, 2013
- Report Date
- February 5, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN INSERT. IMPLANTS WERE UNREADABLE TO GET CATALOG NUMBERS AND LOT CODES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. OTHER DEVICES LISTED IN THIS REPORT: UNKNOWN FEMUR, UNKNOWN BASEPLATE, UNKNOWN PATELLA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT HAD AN INFECTED FIVE YEAR OLD KNEE. SURGEON PERFORMED WASHOUT AND PLACED ANTIBIOTIC SPACER IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84279 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JWH | STRYKER ORTHOPAEDICS-MAHWAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |