BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE

    MDR report key: 6586064 · Received May 23, 2017

    Report

    Report Number
    0001825034-2017-03383
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    April 24, 2017
    Report Date
    June 28, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 650-0661 DELTA CERAMIC FEM HD 36/0MM 2016110486 00875705401 SHELL WITH CLUSTER HOLES POROUS 54 MM O.D. SIZE JJ FOR USE WITH JJ LINERS 63452139, 00875101136 LINER NEUTRAL 36 MM I.D. SIZE JJ FOR USE WITH 54 MM O.D. SIZE JJ SHELL 63306301 00625006535 BONE SCR 6.5X35 SELF-TAP 63308794. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION OF THE STEM FOUND NO MAJOR DAMAGE. A SMALL AMOUNT OF COATING WEAR WAS OBSERVED NEAR THE PROXIMAL END OF THE STEM. AS STATED IN THE HCP ASSESSMENT OF THE PROVIDED PRE-REVISION RADIOGRAPHS SHOWED ACETABULAR CUP LATERAL ANGLE OF INCLINATION APPEARS GROSSLY WITHIN LEWINNEK'S "SAFE ZONE". THE CORTEX OF THE FEMORAL CALCAR IS SCLEROTIC. HOWEVER, NO SPECIFIC CALCAR FRACTURE OR SUBSIDENCE IS DIAGNOSED ON THE IMAGES PROVIDED. IF PRESENT, CALCAR FRACTURE AND/OR SUBSIDENCE MAY NOT BE WELL RECOGNIZED DUE TO OSTEOPENIA, SUBOPTIMAL IMAGE QUALITY AND LACK OF BASELINE IMAGING. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION BY ZIMMER BIOMET U.S.; HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K101086. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH POST INITIAL IMPLANTATION DUE TO PAIN, CALCAR FRACTURE AND SUBSIDENCE. IT IS UNKNOWN IF THE FRACTURE OCCURRED DUE TO THE SHIFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365920 TAPERLOC COMPLETE PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3795963

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R