BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019

    MDR report key: 2964565 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00695
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K040734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE CATALOG AND LOT NUMBERS WERE CORRECTED BASED ON THE RETURNED PRODUCT. THE MODULAR RESTORATION CONE BODY WAS RETURNED IN ITS INNER BLISTER, WITH BOTH END FOAMS IN PLACE. THE TOP FOAM (IN WHICH THE LOCKING BOLT IS PLACED), OUTER BLISTER, TYVEK LIDS OR CARTON WERE NOT RETURNED. THE FACT THAT THE TOP FOAM WAS NOT RETURNED WOULD SUGGEST THAT IT WAS DISCARDED BY THE OR STAFF. IT IS A POSSIBILITY THAT THE BOLT COULD HAVE BEEN ACCIDENTLY DISCARDED WITH THE TOP FOAM. DEVICE HISTORY REVIEW INDICATES ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT WHEN THE CONE CONICAL BODY WAS OPENED DURING SURGERY, THE BOLT WAS MISSING. THE SALES REP REPORTED THAT A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT WHEN THE CONE CONICAL BODY WAS OPENED DURING SURGERY, THE BOLT WAS MISSING. THE SALES REP REPORTED THAT A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68102 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 24408001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other