BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD -3MM NK

    MDR report key: 8335981 · Received February 13, 2019

    Report

    Report Number
    0001825034-2019-00515
    Event Type
    Injury
    Date Received
    February 13, 2019
    Report Date
    February 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:11-105904 LOT NUMBER: UNKNOWN BRAND NAME: ARCOM RINGLOC LINER, CATALOG NUMBER:104154 LOT NUMBER: UNKNOWN BRAND NAME: RINGLOC SHELL, CATALOG NUMBER:162342 LOT NUMBER: UNKNOWN BRAND NAME: BI-METRIC STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00516. TWO X-RAYS WERE PROVIDED WHICH WERE FURTHER ASSESSED AND THE REPORT STATED THAT THERE WAS A SUPERIOR DISLOCATION OF THE FEMORAL HEAD. ASYMMETRIC POSITIONING OF THE FEMORAL HEAD SUGGESTING POLYETHYLENE WEAR. NO OTHER ANOMALIES WERE NOTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DISLOCATED APPROXIMATELY 24 YEARS POST IMPLANTATION. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. X-RAYS WERE PROVIDED WHICH SUGGEST SUPERIOR DISLOCATION OF THE FEMORAL HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130656 28MM DIA COCR MOD HD -3MM NK PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other