BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL LARGE DIAMETER HEAD 48/N

    MDR report key: 1842828 · Received September 16, 2010

    Report

    Report Number
    9613350-2010-00440
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    June 17, 2010
    Report Date
    December 11, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICE IN THE U.S. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR EXPLANTED DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN 07/2008. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE (S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A REVISION SURGERY OCCURRED DUE TO SUSPECTED ALLERGIC REACTION / LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METASUL LARGE DIAMETER HEAD 48/N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH NA 2380646

    Patients

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