BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32MM -4 LFIT V40 HEAD

    MDR report key: 4251256 · Received November 14, 2014

    Report

    Report Number
    0002249697-2014-04271
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K010757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SEATING/LOCKING ISSUES INVOLVING A METAL HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: INSPECTION OF THE DEVICE BY THE MANUFACTURING CELL NOTED A LIP AT THE BOTTOM OF THE MACHINED TAPER, WHICH WOULD PREVENT A FUNCTIONAL LOCK. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN TWO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE SEATING/LOCKING ISSUE WAS CAUSED BY A LIP AT THE BOTTOM OF THE MACHINED TAPER, WHICH WOULD PREVENT A FUNCTIONAL LOCK. NC WAS ISSUED FOR LFIT V40 HEADS - SEATING/LOCKING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEMORAL HEAD WOULD NOT LOCK ONTO FEMORAL STEM DURING THE PRIMARY SURGERY. NEW HEAD WAS GIVEN AND IT LOCKED IN PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEMORAL HEAD WOULD NOT LOCK ONTO FEMORAL STEM DURING THE PRIMARY SURGERY. NEW HEAD WAS GIVEN AND IT LOCKED IN PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736265 32MM -4 LFIT V40 HEAD IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 48681201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other