BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 58/52 R

    MDR report key: 2132154 · Received June 1, 2011

    Report

    Report Number
    9613350-2011-00337
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4) WHICH MARKETS THE DEVICES IN THE (B)(4). THE MANUFACTURER DID NOT YET RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR 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. AS SOON AS ADDITIONAL INFORMATION HAS BECOME AVAILABLE AND / OR THE DEVICE(S) HAVE BEEN RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER RECEIVED AND REVIEWED SURGERY REPORTS FROM REVISION WHICH DID NOT LEAD TO A NEW CONCLUSION. 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 TILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 25, 2015. THE DEVICES WERE RETURNED AND THE RESULT OF THE VISUAL EXAMINATION HAS BEEN MADE AVAILABLE. SCRATCHES AND MINOR THIRD BODY MATERIAL GROWTH PRESENT ON THE POROUS COATING OF THE DUROM ACETABULAR COMPONENT. SCRATCHING AND SCUFFING PRESENT ON THE ARTICULATING SURFACE OF THE DUROM ACETABULAR COMPONENT. MODERATE SCRATCHING PRESENT ON RIM SEGMENTS B, C, AND F; SCALLOPS BC AND FA; AND CUT-OUT CD. MATERIAL DEFORMATION PRESENT ON RIM SEGMENT C AND CUT-OUT CD OF THE DUROM ACETABULAR COMPONENT. THIRD BODY MATERIAL GROWTH PRESENT ON SCALLOP FA OF THE DUROM ACETABULAR COMPONENT. THE RESULT OF THE EXAMINATION DID NOT CHANGE THE RESULTS OF THE PREVIOUS ASSESSMENT IN WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED IN THE MEANWHILE. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT WAS SCHEDULED FOR REVISION DUE TO SUSPECTED LOOSENING OF THE ACETABULAR COMPONENT (DUROM).

    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 2427688

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R