BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 48/42 H

    MDR report key: 3911514 · Received May 27, 2014

    Report

    Report Number
    9613350-2014-03562
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 14, 2014
    Report Date
    December 20, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 USA, 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 USA WAS COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE USA. A SIMILAR CUP, COMPATIBLE WITH THE METSUL LDH FEMORAL HEAD, IS CLEARED IN THE USA AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN JULY 2009 AS NOTIFICATION Z-2415/2426-2008. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION. ZIMMER' S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 48/42 CODE H ON THE RIGHT SIDE ON (B)(6) 2008. CURRENTLY, THE PATIENT IS BEING MONITORED DUE TO UNKNOWN REASONS. LEFT COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310483 DUROM ACETABULAR COMPONENT 48/42 H DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH N/A 2426677

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other