BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 56/50 CODE P

    MDR report key: 3760855 · Received April 7, 2014

    Report

    Report Number
    9613350-2014-03425
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 10, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENT (USER REPORT) WAS RECEIVED. 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 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)(4) 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

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 56/50 CODE P ON (B)(6) 2007. THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO WEAR AND OSTEOLYSIS. IN THE USER REPORT THE FOLLOWING STATEMENT WAS REPORTED: "RADIOLOGICALLY SIGNIFICANT INCREASE IN RUNNING A ROUGH OSTEOLYSIS AND BLACK CONE AT THE TRANSITION CONE / NECK ABUNDANT METAL ABRASION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205724 DUROM ACETABULAR COMPONENT 56/50 CODE P DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH 2386763

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R