BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL WITH CLUSTER HOLES POROUS 52 MM

    MDR report key: 8252345 · Received January 16, 2019

    Report

    Report Number
    0001822565-2019-00237
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    June 1, 2018
    Report Date
    January 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K091508
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 00877503602, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, LOT # 2854775. ITEM # 00877501036, BIOLOX® DELTA CERAMIC TAPER LINER, LOT # 2884277. ITEM # 01.00551.306, FITMOR HIP STEM, LOT # 2877006. THE EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS CONFIRMED WITH THE REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE SHELL TAPER WEAR IS FROM THE REPORTED LINER FRACTURE WHICH HAS LEAD TO THE INCREASED METAL DEBRIS IN THE PATIENT SYSTEM. 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 THE CUP WAS REVISED DUE TO METALLOSIS APPROXIMATELY ONE YEAR POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46852 SHELL WITH CLUSTER HOLES POROUS 52 MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 63488339

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R