BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE PRIMARY FEMORAL POROUS-BONEMASTER REDUCED DISTAL

    MDR report key: 7752346 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-04771
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    May 14, 2018
    Report Date
    August 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT BORN SOMETIME IN THE YEAR (B)(6). UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000850 - G7 NEUTRAL E1 LINER 32MM F - 3553749. 110010246 - G7 OSSEOTI 4 HOLE SHELL 56MM F - 6174634. 163674 - 32MM COCR MOD HD +6MM NO SKIRT - 408170. REPORT SOURCE: (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K101086. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE DEVICE REMAINS IMPLANTED. 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. REVIEW OF PROVIDED X-RAYS SHOWS SUBSIDENCE OF FEMORAL COMPONENT OF THE RIGHT HIP. OVERALL FIT AND ALIGNMENT APPEAR ANATOMIC, AND BONE QUALITY APPEARS NORMAL. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION 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 THAT A PATIENT EXPERIENCED STEM SUBSIDING APPROXIMATELY TWO MONTHS POST INITIAL HIP ARTHROPLASTY. NO REVISION SURGERY IS BEING PLANNED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593607 TAPERLOC COMPLETE PRIMARY FEMORAL POROUS-BONEMASTER REDUCED DISTAL PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6103479

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other