BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44 CODE J

    MDR report key: 3841239 · Received May 13, 2014

    Report

    Report Number
    9613350-2014-03513
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    October 25, 2010
    Report Date
    April 14, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE OR X-RAYS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE USA, ZIMMER IDENTIFIED THAT THE MOST PROBABLY 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 INITIATED IN NOVEMBER 2009 AND REPORTED TO THE (B)(6) AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE USA. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE USA AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN JULY 2008 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. (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 50/44 CODE J ON THE LEFT SIDE ON (B)(6) 2008. THE PATIENT WAS REVISED ON (B)(6) 2011 DUE TO PAIN AND LOOSENING. ON (B)(6) 2010 THE PATIENT WAS DIAGNOSED WITH SIGNIFICANT PROBLEMS WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285509 DUROM ACETABULAR COMPONENT 50/44 CODE J DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R