BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44 CODE J

    MDR report key: 2932481 · Received January 24, 2013

    Report

    Report Number
    9613350-2013-01295
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 10, 2013
    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

    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 US, 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 US WAS INITIATED IN (B)(4) 2009 AND REPORTED TO (B)(4) AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE US A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE US AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN (B)(4) 2008 AS CORRECTION (B)(4). SHOULD ADDITIONAL INFORMATION 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. (B)(4)

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON JANUARY 18, 2017 TO ENTER ADDITIONAL INFORMATION WHICH WAS RECEIVED ON JANUARY 16, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM ACETABULAR COMPONENT 50/44 CODE J ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2012 DUE TO PAIN. PATIENT'S DATE OF BIRTH IS (B)(6).

    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 50/44 CODE J ON THE LEFT SIDE. THE PATIENT WAS REVISED DUE TO PAIN, FLUID ACCUMULATION AND ARMD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34547 DUROM ACETABULAR COMPONENT 50/44 CODE J DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2382469

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R