BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 58/52 CODE R

    MDR report key: 3010291 · Received March 14, 2013

    Report

    Report Number
    9613350-2013-01429
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    September 13, 2012
    Report Date
    March 4, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    Z-2415/2426-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES 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 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 MANUFACTURER'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. A CLEAR CORRELATION BETWEEN THE DEVELOPED METAL ALLERGY OF THE PT AND THE PRODUCT CANNOT BE RULED OUT AS IT IS ALREADY KNOWN FOR SIMILAR METAL ON METAL (MOM) DEVICES FROM LITERATURE. OUR INVESTIGATION HAS SHOWN THAT METAL ION MEASUREMENTS FOR THE DUROM SYSTEM ARE COMPARABLE TO OTHER MOM DEVICES IN THE MARKET. AN ALLERGIC REACTION CAN BE AN INHERENT POST-OPERATIVE SIDE EFFECT AS STATED IN ZIMMER'S IFU (D011500213). THIS IS UNFORTUNATELY PT DEPENDENT AND CAN OCCUR WITH A LOW PERCENTAGE RATE WITH ALL KIND OF METAL ON METAL BASED PRODUCTS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE OR THE DEVICES BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A DUROM ACETABULAR COMPONENT 58/52 CODE R ON AN UNKNOWN DATE. A REVISION SURGERY IS PLANNED ON (B)(6) 2013 DUE TO PAIN, METAL ALLERGY AND ELEVATED COCR LEVEL. "X-RAYS SHOWED PROGRESSIVE LYSIS OF BONE AROUND THE PROXIMAL FEMUR AND CALCAR. THE BONE LOSS IS ATTRIBUTED TO A LOW GRADE INFLAMMATORY RESPONSE TO METAL DEBRIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108150 DUROM ACETABULAR COMPONENT 58/52 CODE R DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH 2316612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other