BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL HEAD

    MDR report key: 7539954 · Received May 24, 2018

    Report

    Report Number
    0001825034-2018-03514
    Event Type
    Injury
    Date Received
    May 24, 2018
    Report Date
    May 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 103535; SCREW; 088740, 13-104150; MALLORY HEAD SHELL; 429660, 103534; SCREW; 172440, X180309; BIMETRIC STEM; 666420, 11-105903; RINGLOC LINER; 034840. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED .REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. DEVICE HISTORY RECORD DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE IS NOT REPORTABLE AS IT WAS NOT INVOLVED IN THE EVENT AND DID NOT MALFUNCTION. 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 A PATIENT HAS BEEN INDICATED FOR HIP REVISION APPROXIMATELY 13 YEARS POST-IMPLANTATION DUE TO LINER WEAR. NO REVISION HAS BEEN REPORTED TO DATE. SUBLUXATION WAS NOTED IN REVIEW OF X-RAYS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382282 COCR FEMORAL HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 122780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other