FDA Adverse Event
Injury
Summary report: N
SERIES 7000 STANDARD TIBIA
MDR report key: 2724672
·
Received August 29, 2012
Report
- Report Number
- 2249697-2012-01396
- Event Type
- Injury
- Date Received
- August 29, 2012
- Date of Event
- August 13, 2012
- Report Date
- August 13, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K9101990
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENT REPORT. CATALOG NUMBER AND LOT CODE OF OTHER DEVICE LISTED IN THIS REPORT: CAT # 73-0710 LOT # G610 DESCRIPTION: SCORPIO M-DOME PATELLA. CAT # 70-4107L LOT # K00M148 DESCRIPTION: SCORPIO CR WAFFLE FEMUR LFIT W/POSTS. CAT # 72-2-0512 LOT # 53107501 DESCRIPTION: SCORPIO CR TIB INSERT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S KNEE FAILURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT, FAILED TKA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES 7000 STANDARD TIBIA | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | T00T105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |