BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44 CODE J

    MDR report key: 3242953 · Received July 19, 2013

    Report

    Report Number
    9613350-2013-01755
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    February 14, 2012
    Report Date
    July 11, 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. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. 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 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 NOVEMBER 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 CORRECTION 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).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON (B)(6) 2017 TO ENTER ADDITIONAL INFORMATION WHICH WAS RECEIVED ON (B)(6) 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).

    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) 2009. THE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PAIN. DURING SURGERY, PUS WAS FOUND IN THE HIP JOINT. THEREFORE, THE SURGEON DECIDED TO SIMPLY REMOVE THE PROTHESIS AND TO PUT THE PATIENT ON INTRAVENOUS ANTIBIOTICS.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 50/44 CODE J. THE PATIENT WAS REVISED DUE TO PAIN, LOOSENING, FLUID COLLECTION, METAL ALLERGY AND INFECTION. THIS IS A BILATERAL CLAIM. RIGHT SIDE COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338100 DUROM ACETABULAR COMPONENT 50/44 CODE J DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2462649

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R