BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 52/46 CODE L

    MDR report key: 2871533 · Received December 6, 2012

    Report

    Report Number
    9613350-2012-01127
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ZIMMER GMBH
    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 LOT NUMBERS WERE RECEIVED FOR THE DEVICES AND THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITY OUTSIDE THE U.S., ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUT THAT RESULTED FROM USE OF SURGICAL TECHNIQUE 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 CORRECTIVE Z-2415/2426-2008. ONCE THE IMPLANTS ARE RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND THE RESULTS BECOME AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PT RECEIVED AN ACETABULAR COMPONENT ON (B)(6) 2008 AND UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO ELEVATED ION LEVEL IN HER BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 52/46 CODE L DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2418282

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R