BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI TS BASEPLATE SIZE 3

    MDR report key: 2112253 · Received April 29, 2011

    Report

    Report Number
    2249697-2011-00593
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K053514
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRI RM/LL TIB AUG SZ3 10MM, CAT # 5546-A-302, LOT # N3N06D WAS ALSO LISTED IN THIS REPORT. AT THE PRESENT TIME IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE FOLLOWING TWO OTHER DEVICES (CHECKED AFTER THE SURGICAL PROCEDURE) WERE ALSO LISTED IN THIS REPORT: TRI TS BASEPLATE SIZE 7, CAT # 5521-B-700, LOT # UNK; TRI RM/LL TIB AUG SZ7 10MM, CAT # 5546-A-702, LOT # UNK. INFORMATION RECEIVED INDICATED THAT THE SURGEON REFUSED TO RETURN THESE DEVICES UNTIL THE END OF INVESTIGATION.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THROUGH OUR SALES REP, F.T., THAT: "THE TIBIAL WEDGE N. 3 OF 10MM DURING THE ASSEMBLY MADE THE RIGHT SOUND "CLICK" THAT INDICATED THAT THE PRODUCT WAS ASSEMBLED CORRECTLY. IN THE POST-OP X RAYS THERE WAS A SMALL ZONE OF LIGHT BETWEEN THE WEDGE AND THE BASEPLATE, MY OPINION IS THAT WHEN I TRIED TO IMPACT THE TIBIA ON THE BONE, THE WEDGE OPENED PERIPHERICALLY AT THE TIBIAL BASEPLATE SIDE (OF ABOUT 1-2 MM)." AFTER THE SURGICAL PROCEDURE, OUT OF THE THEATRE, THE SURGEON OPENED ANOTHER WEDGE (7 TIBIA AND A 7/10MM WEDGE) TO EVALUATE IF THE ISSUE WERE RELATED TO THE PRODUCT OR TO THE PROCEDURE. THE SURGEON REPEATED ALL THE PASSAGES DONE PREVIOUSLY IN THE OPERATION ROOM. AFTER HE CLOSED THE SCREW, THE WEDGE REMAINED DETACHED PERIPHERICALLY ON ONE SIDE OF THE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI TS BASEPLATE SIZE 3 IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA BDBE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other