FDA Adverse Event
Injury
Summary report: N
SCORPIO CR WAFFLE FEMUR LFIT W/POSTS
MDR report key: 1780413
·
Received July 26, 2010
Report
- Report Number
- 2249697-2010-00900
- Event Type
- Injury
- Date Received
- July 26, 2010
- Date of Event
- July 2, 2010
- Report Date
- July 2, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K974556
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: SERIES 7000 STANDARD TIBIA, CAT# 7115-0007; LOT# T98N190. SCORPIO CR TIB INSERT, CAT# 72-2-0708; LOT# 35865301. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INSTABILITY. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. THE X-RAYS AND MEDICAL RECORDS WERE REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "PATIENT HAD REVISION DUE TO TRAUMA OF THE KNEE CAUSING INSTABILITY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO CR WAFFLE FEMUR LFIT W/POSTS | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | K98N447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |