BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE

    MDR report key: 6511676 · Received April 21, 2017

    Report

    Report Number
    3002806535-2017-00238
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    March 28, 2017
    Report Date
    July 13, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. THE MHR RELATED TO THE INVOLVED PRODUCT HAS BEEN REVIEWED AND DOES NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. ALL THE LOT (12 UNITS) WAS ACCEPTED AT THE TIME OF MANUFACTURING. A TAPERLOC STEM, M2A-MAGNUM FEMORAL HEAD AND M2A-MAGNUM TAPER ADAPTOR WERE REVISED AFTER APPROXIMATELY 5 YEARS DUE TO FRACTURE OF THE FEMORAL STEM. EXAMINATION OF THE FEMORAL STEM INDICATES THAT IT WAS WELL FIXED TO THE FEMUR. THE ARTICULATING SURFACE OF THE M2A-MAGNUM HEAD SHOWED ONLY LIGHT SCRATCHING AND SMALL REGIONS OF WEAR. THE FRACTURED TAPER DISPLAYED A REDUCTION IN SECTION DUE TO WEAR THAT COULD INDICATE SUBOPTIMAL ASSEMBLY. EVIDENCE OF FRETTING RESIDUE AROUND THE BORE AND OVER HALF OF THE FRACTURE SURFACE AND THE PRESENCE OF BEACHMARKS INDICATE THAT A FATIGUE PROCESS OCCURRED PRIOR TO FRACTURE. FROM THE DOCUMENTATION REVIEW IT CAN BE CONCLUDED THAT THE PRODUCT WAS LIKELY CONFORMING TO MANUFACTURING SPECIFICATION WHEN IT LEFT ZIMMER BIOMET CONTROL. THE DEFINITE ROOT CAUSE FOR THE FAILURE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IMPLANTED ON UNKNOWN DATE APPROXIMATELY FIVE YEARS PRIOR TO REVISION DATE. THIS PRODUCT IS MANUFACTURED BY (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K101086. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY FIVE YEARS POST-IMPLANTATION. THE PATIENT FELT A STRONG PAIN IN A SPRAINED FOOT DURING A WALK. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292382 TAPERLOC COMPLETE PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 2512009

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R M2A MAGNUM HEAD PN157452 LN2035169| RECAP ACETABULAR SHELL PN157858 LN2466643