FDA Adverse Event
Injury
Summary report: N
SCORPIO PS TIB INSERT
MDR report key: 2612807
·
Received June 6, 2012
Report
- Report Number
- 2249697-2012-00716
- Event Type
- Injury
- Date Received
- June 6, 2012
- Date of Event
- May 23, 2012
- Report Date
- May 23, 2012
- Manufacturer
- STRYKER ORTHOPAEDIC MAHWAH
- Product Code
- MBH
- PMA / PMN Number
- K033971
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: DESC: SERIES 7000 STANDARD TIBIA: CAT #: 7115-0011, LOT NUMBER: T04W1234. DESC: SCORPIO M-DOME PATELLA: CAT #: 73-0110, LOT #: R750. DESC: SCORPIO PS FEMUR WAFFLE POSTS W/LFIT: CAT # 71-4511R, LOT K04T110. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INSTABILITY. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, PT WAS REVISED DUE TO INSTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO PS TIB INSERT | IMPLANT | MBH | STRYKER ORTHOPAEDIC MAHWAH | NA | 220115801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |