BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LFIT MORSE TAPER HEAD

    MDR report key: 3970177 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02954
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    March 26, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REVISION SURGERY INVOLVING A LFIT MORSE TAPER HEAD WAS REPORTED. THE EVENT WAS CONFIRMED AS THE DEVICE WAS RETURNED. HOWEVER, THE REASON FOR REVISION IS UNKNOWN. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: INSPECTION OF THE RETURNED DEVICE FOUND NO MATERIAL OR MANUFACTURING DEFECTS. -MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: NOT PERFORMED AS THE REASON FOR REVISION IS UNKNOWN. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. THE REPORTED DEVICE WAS IMPLANTED FOR APPROXIMATELY 19 YEARS. THE STEM AND HEAD SYSTEM IS DESIGNED TO PROVIDE A SECURE LOCK BETWEEN COMPONENTS AND PREVENT THE HEAD FROM DISASSOCIATING FROM THE STEM. THEREFORE, THE DIFFICULTY REMOVING THE HEAD FROM THE STEM INDICATES THE DEVICE MET THE INTENDED DESIGN PURPOSE 19 YEARS POST-OP. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IN 1996, THE BHA WAS DONE WITH OMNIFIT STEM AND SYSTEM1 BIPOLAR CUP AND HEAD. THE REVISION SURGERY WAS DONE IN (B)(6) 2014. AT FIRST DR. THOUGHT TO REVISE HEAD AND BIPOLAR CUP, BUT THE HEAD WAS NOT REMOVED FROM STEM AND BOTH OF THEM WERE EXPLANTED.

    Description of Event or Problem · 1

    IN 1996, THE BHA WAS DONE WITH OMNIFIT STEM AND SYSTEM1 BIPOLAR CUP AND HEAD. THE REVISION SURGERY WAS DONE IN (B)(6) 2014. AT FIRST DR. THOUGHT TO REVISE HEAD AND BIPOLAR CUP, BUT THE HEAD WAS NOT REMOVED FROM STEM AND BOTH OF THEM WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448374 LFIT MORSE TAPER HEAD IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH HN34B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention