BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL DUROM, COMPONENT FOR ACETABULUM, SIZE 52

    MDR report key: 3201995 · Received June 26, 2013

    Report

    Report Number
    9613350-2013-01671
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    March 6, 2013
    Report Date
    September 4, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL 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 CORRECTION IN JULY 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED.(B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM HIP GENERIC ON THE RIGHT SIDE ON (B)(6) 2008. DUE TO METAL ALLERGY, THE PT WAS REVISED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290629 METASUL DUROM, COMPONENT FOR ACETABULUM, SIZE 52 DUROM ACETABULAR COMPONENT LZO ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Hospitalization| R