BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPRO PSL HIP

    MDR report key: 608093 · Received May 26, 2005

    Report

    Report Number
    1833506-2005-00003
    Event Type
    Injury
    Date Received
    May 26, 2005
    Date of Event
    April 9, 2005
    Report Date
    May 25, 2005
    Manufacturer
    BIOPRO, INC.
    Product Code
    KWY
    PMA / PMN Number
    K922500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILED IMPLANT WAS EVALUATED FOR METALLURGICAL DEFECTS BY CLIMAX RESEARCH SERVICES. CLIMAX RESEARCH SERVICES. CLIMAX RESEARCH FOUND THE FOLLOWING. THEY OBSERVED NO MAJOR MATERIAL DEFECTS. THE FRACTURE SURFACES CONTAINED A HIGH AMOUNT OF POST FRACTURE DAMAGE. THE FRACTURE SURFACE CONTAINED "BEACH MARKS" WHICH ARE EVIDENCE OF FATIGUE FRACTURE. A CRACK PARALLEL TO THE FRACTURE PROPAGATED TO APPROXIMATELY 50% OF THE STEM THICKNESS. THE SEVERITY OF THIS CRACK INDICATES THAT THE PART SURVIVED A HIGH NUMBER OF CYCLES PRIOR TO FRACTURE. THE CORE OF THE SHAFT FRACTURED DUE TO METAL FATIGUE. BASED ON THE INFORMATION, FURTHER TESTING WAS CONDUCTED BY BIOMEDCHANICS R&D LLC. HOWEVER, THE IMPLANT WAS TESTED SIMULATING NORMAL SUPPORT FOR THE DEVICE WHEN PROPERLY IMPLANTED AS OPPOSED TO THE ASTM METHOD REQUIRED BY THE FDA, WHICH SUPPORTS THE DEVICE NEAR THE CENTER OF THE STEM SIMULATING BONE RESORBTION AND MINIMAL SUPPORT. THE DEVICE WAS SUPPORTED DIRECTLY UNDER THE COLLAR AND THE LOAD WAS APPLIED PERPENDICULAR TOTHE PLATFORM, AS THE DEVICE WAS INTENDED. WHEN TESTED IN THIS FASHION, THE DEVICE FAILED AT THE SAME LOCATION AS THE DEVICE IN QUESTION IN THIS COMPLAINT. WE WERE ABLE TO DUPLICATE THE FAILURE. ADDITIONAL TESTING WAS CONDUCTED TO DETERMINE THE MAXIMUM LOAD THE DEVICE CAN WITHSTAND OVER 10 MILLION CYCLES. IT WAS DETERMINED THAT THE ENDURANCE LOAD LIMIT FOR THE DEVICE WAS 2200 LBF. USING THE RESULTANT FORCES FOR A ONE LEG STANCE, THE MAXIMUM BODY WEIGHT FOR EACH LENGTH OF THE FEMORAL HEAD IMPLANTS WAS CLACULATED. THE TENSILE STRENGTH OF THE COCR MATERIAL BY ASTM STANDARDS IS 65,000PSI. A SAFETY FACTOR OF AN ADDITIONAL 15% WAS USED BRING THE MAX TENSILE STRENGTH TO 55250PSI. WHEN CALCULATED OUT, EACH HEAD LENGTH HAD THE FOLLOWING MAX LOAD. XX LONG: 220LB, X LONG: 260 LB, LONG: 320LB, MED: 420LB, SHORT: 620LB. IT WAS DETERMINED THAT THE X LONG AND XX LONG SIZES NEED TO HAVE A WEIGHT RESTRICTION. ALSO, THE ONLY FAILURE TO DATE THAT HAS BEEN NOTED IS WITH THE XX LONG STEM. THE FMEA AND INPUTS/OUTPUTS CHECK LIST WERE UPDATED TO INCLUDE THE FAILURE MODE. THE FOLLOWING CORRECTIVE ACTION IS INDICATED. LABEL ALL XX LONG AND X LONG FEMORAL HEADS WITH THE NEW WEIGHT RESTRICTIONS. NOTIFY THE USING SURGEONS OF THE NEW WEIGHT RESTRICTIONS. PLACE A LETTER 510K FILE OF THE NEW RESTRICTIONS.

    Description of Event or Problem · 1

    PATIENT WAS DOING PHYSICAL ACTIVITY WORKING IN GARDEN WHEN TRUNNION FRACTURED ON HIP STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO PSL HIP N. 6 SHORT HIP STEM KWY BIOPRO, INC. 10135 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention