BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 52/46 CODE L

    MDR report key: 3010289 · Received March 14, 2013

    Report

    Report Number
    9613350-2013-01421
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    Z-2415/2426-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW AS THE PT HAS NOT BEEN REVISED. 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 OF 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 RETRAINING 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. 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. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A DUROM ACETABULAR COMPONENT 52/46 CODE L ON (B)(6) 2008. THE PT IS CURRENTLY BEING MONITORED DUE TO PAIN, FLUID COLLECTION AND ELEVATED COCR LEVEL. IT IS UNKNOWN AT THIS TIME IF A REVISION SURGERY IS IN DISCUSSION OR HAS TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108444 DUROM ACETABULAR COMPONENT 52/46 CODE L DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH 2363867

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R