FDA Adverse Event
Injury
Summary report: N
SCORPIOFLEX TOTAL KNEE PS
MDR report key: 2182477
·
Received July 19, 2011
Report
- Report Number
- 2249697-2011-01085
- Event Type
- Injury
- Date Received
- July 19, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 29, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K041591
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: SERIES 7000 STANDARD TIBIA CAT# 7115-0009, LOT# M34MDA. UNKNOWN FEMUR; CAT# UNK, LOT# UNK, UNKNOWN PATELLA; CAT# UNK, LOT# UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S STIFFNESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "DEVICES REMOVED FOR STIFFNESS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIOFLEX TOTAL KNEE PS | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | 1ZLEW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |