BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44

    MDR report key: 2771981 · Received October 2, 2012

    Report

    Report Number
    9613350-2012-00937
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    March 20, 2012
    Report Date
    September 4, 2012
    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

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE NOT PROVIDED AND THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL 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 AS CLOSED. ZIMMER REF #(B)(4). THIS PT ALSO HAD A SURGERY ON HER RIGHT HIP, ON (B)(6) 2011. REVISION SURGERY WAS ON (B)(6) 2011. (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. VERY LIGHT SIGNS OF INGROWTH PRESENT ON THE POROUS SIDE OF THE ACETABULAR COMPONENT. THERE IS ALSO A SECTION OUTLINED BELOW THAT WAS CHIPPED/DENTED. LIGHT THIRD BODY MATERIAL PRESENT ON THE ARTICULATING SURFACES OF BOTH THE ACETABULAR COMPONENT AND HEAD. THE RESULT OF THE EXAMINATION DID NOT CHANGE THE RESULTS OF THE PREVIOUS ASSESSMENT IN WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED IN THE MEANWHILE. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B)(6) 2007 THE PT RECEIVED AN ACETABULAR CUP, LEFT SIDE, AND UNDERWENT REVISION SURGERY DUE TO PAIN AND LOOSENING ON (B)(6)2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 50/44 DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2357527

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R