FDA Adverse Event
Injury
Summary report: N
SCORPIO PS FEMUR WAFFLE POSTS W/LFIT
MDR report key: 2116478
·
Received June 1, 2011
Report
- Report Number
- 2249697-2011-00803
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- May 10, 2011
- Report Date
- May 10, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K962152
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: SERIES 7000 STANDARD TIBIA, CAT# 7115-0011, LOT# T03L497. SCORPIO TOTAL KNEE PS TIBIAL BEARING INSERT, CAT# 72-13-1112, LOT# 21009901. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PT PAIN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER MULTIPLE KNEE EFFUSIONS AND COMPLAINT OF PAIN, DR (B)(6) DECIDED TO BRING THE PT TO THE OPERATING ROOM AND REVISE THE KNEE WITH THE TS IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO PS FEMUR WAFFLE POSTS W/LFIT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | K03L864 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |