BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACET CMPNT 52/46 L

    MDR report key: 12238341 · Received July 28, 2021

    Report

    Report Number
    0009613350-2021-00354
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    September 26, 2019
    Report Date
    July 28, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    PMA / PMN Number
    K053536
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. MEDICAL PRODUCTS: METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20; CATALOG NO#: 01.00185.146; LOT#: 236535. METASUL LDH, HEAD, 46, CODE L, TAPER 18/20; CATALOG NO#: 01.00181.460; LOT#: 2320777. FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY STANDARD NECK OFFSET, SIZE 13 138 MM STEM LENGTH CEMENTLESS, 44/7.5; CATALOG NO#: 00-7864-013-00; LOT#: 60638096. THERAPY DATE: (B)(6) 2019. THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. 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 (B)(6) 2008 AS REFERENCED. 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 GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A DUROM ACETABULAR COMPONENT ON THE LEFT SIDE AND UNDERWENT A REVISION SURGERY DUE TO METALLOSIS AND PSEUDO TUMOR FORMATION ALONG WITH GLUTEUS MEDIUS ABDUCTOR TENDON RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135339 DUROM US ACET CMPNT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2299089

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R