FDA Adverse Event
Injury
Summary report: N
SERIES 7000 SANDARD TIBIA
MDR report key: 2705668
·
Received August 13, 2012
Report
- Report Number
- 2249697-2012-01197
- Event Type
- Injury
- Date Received
- August 13, 2012
- Date of Event
- July 31, 2012
- Report Date
- July 31, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K910990
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 # 71-4107R, LOT # K01W412, DESCRIPTION: SCORPIO PS FEMUR WAFFLE W/FLIT. CAT # 72-3-0712, LOT # 71279201, DESCRIPTION: SCORPIO; CAT # 73-3508, LOT # K179, DESCRIPTION: SCORPIO U-DOME PATELLA.
Description of Event or Problem · 1
IT WAS REPORTED THAT, DOCTOR REVISED PATIENT'S KNEE TO TOTAL STABILIZED PROSTHESIS DUE TO GLOBAL INSTABILITY FROM COLLATERAL LIGAMENT INJURY. THE HOSPITAL WAS NOT ABLE TO OBTAIN THE CATALOG NUMBERS AND LOT CODES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES 7000 SANDARD TIBIA | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | T02A652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |