BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 58/52 CODE R

    MDR report key: 3960479 · Received July 15, 2014

    Report

    Report Number
    9613350-2014-03722
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    July 7, 2014
    Report Date
    January 18, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON FEBRUARY 10, 2016 TO ENTER ADDITIONAL INFORMATION WHICH HAD BEEN RECEIVED ON JANUARY 18, 2016. THE CAUSE FOR THIS COMPLAINT HAS NOT BEEN REPORTED, BUT SINCE THE DATE OF THE IMPLANTATION HAS NOT BEEN PROVIDED, THIS CASE WILL BE TREATED AS A COMPLAINT THAT MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION IN JULY 2008 AS NOTIFICATION (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON FEBRUARY 22, 2017 TO ENTER ADDITIONAL INFORMATION WHICH WAS RECEIVED ON FEBRUARY 20, 2017. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION WHICH WAS REPORTED TO THE FDA IN JULY 2008 AS CORRECTION Z-2415/2426-2008, THERE WILL BE NO FURTHER INVESTIGATION AND ZIMMER (B)(4) WILL CLOSE THIS CASE ONCE AGAIN. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS: (B)(4).

    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 INITIATED IN NOV 2009 AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES 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. ZIMMER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 58/52 CODE R. THE PATIENT WAS REVISED ON UNKNOWN DATE DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 58/52 CODE R ON THE RIGHT SIDE ON (B)(6) 2007. CURRENTLY, THE PT IS BEING MONITORED DUE TO UNK REASONS.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT A PRODUCT LIABILITY CLAIM WAS RAISED. THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 58/52 CODE R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413152 DUROM ACETABULAR COMPONENT 58/52 CODE R DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2363100

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R