BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 58/52 R

    MDR report key: 2083087 · Received April 29, 2011

    Report

    Report Number
    9613350-2011-00281
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    September 29, 2010
    Report Date
    April 12, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN (B)(4). (B)(4), SUSPECTED LOOSENING. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES OR X-RAYS. THE OP REPORT HAS BEEN REVIEWED. IT DOES NOT STATE ANY PECULIARITY. WHERE LOT NUMBERS WERE RECEIVED FROM THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT PRODUCT FAILURE LEAD TO THE ALLEGED EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN 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 CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 07/03/2015. THE DEVICES WERE RETURNED AND THE RESULT OF THE VISUAL EXAMINATION HAS BEEN MADE AVAILABLE. UPDATES REVIEW OF EVENT DESCRIPTION: PRODUCT WAS IMPLANTED ON (B)(6) 2008, AND WAS REVISED ON (B)(6) 2012 DUE TO LOOSENING, FLUID COLLECTION AND CORROSION. DURING THE VISUAL EXAMINATION THE DUROM ACETABULAR COMPONENT PRESENTED MISSING POROUS COATING SECTION NEAR RIM, THIRD PARTY MATERIAL GROWTH WAS PRESENT THROUGHOUT POROUS COATING AND IN BETWEEN CIRCUMFERENTIAL FINS, SCRATCH THAT OCCURRED RADIALLY ACROSS RIM AND ARTICULAR APPEARS 'CLOUDY' DUE TO THE PRESENCE OF THIRD PARTY MATERIAL. METASUL LDH HEAD WITH HEAD ADAPTER PRESENTED MINIMAL SCUFFS ACROSS THE WHOLE ARTICULATING SURFACE, THE MOST NOTICABLE AREA IS NEAR THE RIM AND MODERATE THIRD PARTY MATERIAL IS PRESENT ON THE INNER FACE AND THROUGHOUT THE HEAD CAVITY SURFACE. THE RESULT OF THE EXAMINATION DID NOT CHANGE THE RESULTS OF THE PREVIOUS ASSESSMENT. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH US DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RELAUNCH OF THE US DUROM CUP. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED MEANWHILE. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT BEING MONITORED DUE TO SUSPECTED ACETABULAR CUP LOOSENING. INITIAL SURGERY WAS ON (B)(6) 2008.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT RECEIVED AN ACETABULAR CUP AND HAD TO BE REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 58/52 R DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2348419

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other