BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APR II HIP SYSTEM FEMORAL BROACH

    MDR report key: 1915197 · Received November 2, 2010

    Report

    Report Number
    1822565-2010-01052
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    JDI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THERE IS SOME DAMAGE TO THE SURFACE AROUND THE POST LOCATION. SOME MATERIAL ON THE OUTER EDGE OF THE AREA WHERE THE POST USED TO BE IS SLIGHTLY DEFORMED UPWARD. THE CUTTING TEETH APPEAR TO BE IN GOOD CONDITION. THE MATERIAL HARDNESS OF THE BROACH WAS CHECKED AND FOUND TO BE CONFORMING TO THE SPECIFICATIONS. THE DIMENSIONS WERE ALSO CONFORMING WHERE MEASURED. THE DEVICE HAD A POTENTIAL FIELD AGE OF 3 YEARS AND 2 MONTHS AT THE TIME OF THE EVENT. IT IS UNK IF THE PROPER SURGICAL TECHNIQUE WAS USED TO BROACH THE FEMUR. THE MATING INSTRUMENTATION USED WITH THE BROACH IS UNK. IF AN INCORRECT INSTRUMENT WAS USED WITH THE BROACH, TOGGLE BETWEEN THE BROACH AND THE INSTRUMENT COULD CREATE A LARGE SHEAR FORCE ON THE POST UPON IMPACTION. THE DEFORMED MATERIAL ON THE SURFACE AROUND THE POST MAY INDICATE THAT THE BROACH WAS SUBJECTED TO EXCESSIVE LEVERING FORCES, WHICH COULD LEAD TO POST FRACTURE. THE FRACTURE ALSO COULD HAVE BEEN CAUSED BY FATIGUE DUE TO NORMAL LOADING OVER THE LIFE OF THE DEVICE. BASED ON THE INFO PROVIDED, NO DEFINITIVE CAUSE FOR THE FRACTURE CAN BE DETERMINED WITH CERTAINTY. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS BROACHING THE FEMUR WHEN THE POST ON THE BROACH SNAPPED OFF. ALL PIECES WERE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APR II HIP SYSTEM FEMORAL BROACH HIP PROSTHESIS JDI ZIMMER INC 60763357

    Patients

    Seq Age Sex Outcome Treatment
    1