BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL HEAD

    MDR report key: 7509955 · Received May 14, 2018

    Report

    Report Number
    0002648920-2018-00241
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    June 29, 2016
    Report Date
    June 12, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. REVISION OPERATIVE NOTES STATES THE PATIENT WAS REVISED DUE TO ADVERSE LOCAL TISSUE REACTION SECONDARY TO TRIBOCORROSION. NECROSIS OF THE POSTERIOR PART OF THE GLUTEUS MEDIUS OBSERVED WITH SUBSTANTIAL AMOUNT OF FLUID PRESENT. 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. REPORT 0002648920-2018-00241-1 WAS REPORTED AT MAR 6, 2018. THIS DATE WAS REPORTED INCORRECTLY AS IT SHOULD BE JUN 7, 2018.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00630506240, LINER STANDARD 3.5 MM OFFSET 40 MM, 60799915 00620006222, SHELL POROUS WITH CLUSTER HOLES 62 MM, 60750711 65771100900, FEMORAL STEM 12/14 NECK TAPER, 60738932. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO ALT (ADVERSE LOCAL TISSUE REACTION) SECONDARY TO TRIBOCORROSION. OPERATIVE REPORT NOTED SUBSTANTIAL AMOUNT OF FLUID WAS PRESENT. THERE WAS SOME NECROTIC TISSUE AROUND THE UPPER PORTION OF THE FEMORAL COMPONENT. THERE WAS CORROSION BUILD UP AT THE BASE OF THE HEAD AS WELL AS THE INSIDE OF THE HEAD AND ON THE SURFACE OF THE FEMORAL NECK. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354371 COCR FEMORAL HEAD PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 60785817

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R