BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 3150146 · Received May 30, 2013

    Report

    Report Number
    9613350-2013-01605
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Removal / Correction Number
    Z-2415/2426-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO CLEAR DATE ABOUT THE SURGERY, ONLY 2008 IS MENTIONED. THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE U.S., ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUP THAT RESULTED FROM USE OF SURGICAL TECHNIQUES NOT CONSISTENT WITH THE MANUFACTURER'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETRAINING PROGRAM FOR USERS OUTSIDE THE U.S. WAS INITIATED IN (B)(4) 2009 AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE U.S. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE U.S. AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN (B)(4) 2008 AS CORRECTION (B)(4). SHOULD ADDITIONAL INFORMATION INCLUDING THE FINAL 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 AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM ACETABULAR CUP IN 2008. PATIENT IS BEING MONITORED DUE TO PAIN. IT IS ALSO REPORTED THAT THE PATIENT WAS ORIGINALLY OPERATED IN EUROPE. HOWEVER THERE IS NO INFORMATION AVAILABLE ABOUT THE EXACT COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237760 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT 56/50 CODE P KWA ZIMMER, INC. 2420816

    Patients

    Seq Age Sex Outcome Treatment
    1