BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    MDR report key: 2243794 · Received August 30, 2011

    Report

    Report Number
    9613350-2011-00566
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    September 14, 2009
    Report Date
    August 10, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Removal / Correction Number
    Z-2415/2426-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE EXPLANTED DEVICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE DEVICE WAS DIRECTLY SENT BY THE HOSPITAL TO AN EXTERNAL INVESTIGATION LAB. ZIMMER HAS SO FAR NO ACCESS TO THOSE DATA. 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 MFR'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETAINING PROGRAM FOR USERS OUTSIDE THE U.S. WAS INITIATED IN NOVEMBER 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 JULY 2008 AS CORRECTION Z-2415/2426-2008. SHOULD ADDITIONAL INFO 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. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD A REVISION SURGERY DUE TO UNK REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 54/48 CODE N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER, INC. 2253645

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R