BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V40 COCR LFIT HEAD 36MM/0

    MDR report key: 3031985 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01172
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DIFFICULTY SEATING A V40 COCR LFIT HEAD ONTO A STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS SUCCESSFULLY ASSEMBLED TO A STEM WITH A V40 TAPER. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT RECORDS DID NOT CONTRIBUTE TO THE EVENT. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS. CONCLUSIONS: THE INVESTIGATION CONCLUDED THE RETURNED V40 COCR LFIT HEAD IS FULLY FUNCTIONAL. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE ASSOCIATED STEM WAS NOT RETURNED FOR INVESTIGATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    FEMORAL HEAD DID NOT ENGAGE TRUNNION. WE ONLY CARRY ONE SET OF V40 COCR HEADS AT THE HOSPITAL. THE DOCTOR TRAILED A +5 AND WAS SATISFACTORY.

    Description of Event or Problem · 1

    FEMORAL HEAD DID NOT ENGAGE TRUNNION. WE ONLY CARRY ONE SET OF V40 COCR HEADS AT THE HOSPITAL. THE DOCTOR TRAILED A +5 AND WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135602 V40 COCR LFIT HEAD 36MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MLT9L4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other