FDA Adverse Event
Malfunction
Summary report: N
SCORPIO TOTAL KNEE PS TIBIAL BEARING INSERT
MDR report key: 2090629
·
Received April 19, 2011
Report
- Report Number
- 9616680-2011-00235
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 28, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JWH
- PMA / PMN Number
- K04096
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS: MFR # 2249697-2011-00532, MFR # 2249697-2011-00533.
Description of Event or Problem · 1
END USER REGIONAL CLINIC HOSP REPORTED VIA STRYKER REP IN (B)(6) THAT "ALL IMPLANTS COULDN'T BE INSTALLED INTO INTENDED COMPONENTS. THESE EVENTS OCCURRED DURING THE SURGICAL PROCEDURES, NOTHING HAPPENED TO PTS, OTHER IMPLANTS WERE INSTALLED INSTEAD." ADD'L INFO: "THERE WERE DIFFICULTIES WITH INSERTING THE INSERTS. FINALLY THE OTHERS INSERTS WITH THE SAME CAT. NUMBERS WERE INSERTED. THEY WERE IMPLANTED INTO INTENDED IMPLANTS FOR SCORPIO - TIBIA PLATES 7115-0007 AND 7115-0009."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO TOTAL KNEE PS TIBIAL BEARING INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS CORK | NA | TKM04407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |