BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RNGLOC LNR HWALL 22

    MDR report key: 7252707 · Received February 8, 2018

    Report

    Report Number
    0001825034-2018-00571
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    April 29, 2016
    Report Date
    February 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE ROOT CAUSE FOR THE BEARING WEAR IS DUE TO NORMAL WEAR OVER THE COURSE OF USE (IN-VIVO) AS THE DEVICE WAS IN-VIVO FOR 22 YEARS. 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)(6). CONCOMITANT: 103800, TPRLC REG POR FMRL 7.5X135, 129670; 163660, 28MM DIA COCR MOD HD -6MM NK, 032750. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO POLY WEAR TWENTY-TWO YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97761 ARCOM 28MM RNGLOC LNR HWALL 22 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 790750

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R