BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 56/50 P

    MDR report key: 3946353 · Received July 10, 2014

    Report

    Report Number
    9613350-2014-03697
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    September 24, 2007
    Report Date
    June 13, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 07/04/2015. THE DEVICES WERE RETURNED AND THE RESULT OF THE VISUAL EXAMINATION HAS BEEN MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: PRODUCT WAS IMPLANTED ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2007 DUE TO PAIN AND WEAR. SURGICAL REPORT: THE IMPLANTATION NOTES OF THE HIP STATED THAT THE SURGERY WAS ACCORDING TO STANDARD PROTOCOL. REVIEW OF SURGICAL REPORT DID NOT LEAD TO NEW INFORMATION REGARDING THE REPORTED EVENT. VISUAL EXAMINATION: DURING THE VISUAL EXAMINATION THE DUROM ACETABULAR COMPONENT PRESENTED POROUS COATING WITH HEAVY THIRD BODY MATERIAL AND LIGHT SCRATCHING. METASUL LDH HEAD ADAPTER AND DIAMETER HEAD PRESENTED THIRD BODY MATERIAL PRESENT THROUGHOUT THE INNER CAVITIES. 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. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION 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 NOTIFICATION IN JULY 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGED THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 56/60 P ON THE LEFT SIDE ON (B)(6) 2007. THE PATIENT WAS REVISED ON (B)(6) 2007 DUE TO PAIN. SECOND REVISION CASE: (B)(6). RIGHT SIDE CASE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404890 DUROM US ACETABULAR COMPONENT 56/50 P DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2359668

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R