BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 54/48 N

    MDR report key: 3772117 · Received April 8, 2014

    Report

    Report Number
    9613350-2014-03430
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT HAS NOT BEEN REVISED AND IS CURRENTLY BEING MONITORED. THE CAUSE FOR THIS COMPLAINT HAS NOT BEEN PROVIDED, AND THE DATE OF THE ORIGINAL IMPLANTATION WAS NOT PROVIDED, HENCE ZIMMER WILL TREAT THIS CASE AS IT COULD BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADD'L INFO BECOME AVAILABLE THAT CHANGES THIS ASSESSMENT, AND AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME.(B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 23, 2015. THE CASE WAS REOPENED AND RE-INVESTIGATION WAS PERFORMED. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE COMPATIBILITY CHECK SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. REVIEW OF EVENT DESCRIPTION: PATIENT IS REVISED DUE TO PAIN, ELEVATED COBALT LEVEL, IMPLANT FAILURE. NO BONE INGROWTH TO ACETABULUM. THE RESULT OF THE RE-INVESTIGATION DID NOT CHANGE THE RESULTS OF THE PREVIOUS ASSESSMENT IN WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED IN THE MEANWHILE. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED AGAIN. (B)(4).

    Description of Event or Problem · 1

    IT IS NOW REPORTED THAT A PATIENT WAS IMPLANTED AN DUROM US ACETABULAR COMPONENT 54/48 N ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2014 DUE TO PAIN, ELEVATED COBALT LEVEL, IMPLANT FAILURE. NO BONE INGROWTH TO ACETABULUM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT REC'D A DUROM ACETABULAR COMPONENT (EXACT DEVICE NAME NOT REPORTED). THE IMPLANTATION DATE WAS NOT PROVIDED. THE PT IS CURRENTLY BEING MONITORED DUE TO UNK REASONS. THERE IS A PLAN FOR THE PT TO UNDERGO REVISION SURGERY. NO FURTHER INFO WAS REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212308 DUROM US ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS KWA ZIMMER GMBH 2348417

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R