BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL LDH, HEAD, 48, CODE N, TAPER 18/20

    MDR report key: 12307055 · Received August 11, 2021

    Report

    Report Number
    0009613350-2021-00389
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    May 16, 2019
    Report Date
    August 11, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. CONCOMITANT MEDICAL PRODUCTS: DUROM US ACET CMPNT 54/48 N; CATALOG#: 01.00214.154; LOT#: 2423579, METASUL LDH, HEAD ADAPTER, S, -4, TAPER 12/14-18/20; CATALOG#: 01.00185.145; LOT#: 2421995, FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY EXTENDED NECK OFFSET SIZE 14 149 MM STEM LENGTH CEMENTLESS; CATALOG#: 00-7864-014-20; LOT#: 60892889. THERAPY DATE: (B)(6) 2019. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMERS REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A DUROM CUP ON THE LEFT SIDE AND UNDERWENT A REVISION SURGERY DUE TO PAIN, METALLOSIS, ELEVATED METAL ION LEVELS, DECREASED ACTIVITY OF DAILY LIVING, CORROSION AND ADVERSE LOCAL TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202734 METASUL LDH, HEAD, 48, CODE N, TAPER 18/20 HIP PROSTHESIS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2426404

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R