BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 5096522 · Received September 23, 2015

    Report

    Report Number
    9613350-2015-01304
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    May 19, 2015
    Report Date
    September 8, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2015. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WILL BE INVALIDATED SINCE THE PATIENT WAS ACTUALLY IMPLANTED WITH A TM MODULAR HIP AND NOT WITH A DUROM US ACETABULAR COMPONENT. THEREFORE, ZIMMER (B)(4) WILL CONSIDER THIS CASE AS CLOSED. ZIMMER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON THE RIGHT SIDE ON (B)(6) 2010.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED.IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON AN UNKNOWN SIDE ON (B)(6) 2010. THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO PAIN,LOOSENING AND INFECTION.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED ON FEBRUARY 21, 2017. IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS ACTUALLY IMPLANTED WITH A TM MODULAR HIP (MANUFACTURED BY ZIMMER INC., (B)(4), USA) AND NOT WITH A DUROM US ACETABULAR COMPONENT. THEREFORE, THIS CASE WILL BE INVALIDATED. PLEASE RECTIFY YOUR RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627606 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R