BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 52/46 L

    MDR report key: 4112598 · Received September 10, 2014

    Report

    Report Number
    9613350-2014-03858
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    March 3, 2014
    Report Date
    August 12, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC 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 NOTIFICATION IN JULY 2008. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOMES AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON JULY 05, 2016 TO ENTER ADDITIONAL INFORMATION WHICH WAS RECEIVED ON JUNE 29, 2016. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED, ZIMMER (B)(4) WILL CLOSE THIS CASE ONCE AGAIN. (B)(4).

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 52/46 L. THE PATIENT WAS REVISED DUE TO LOOSENING.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON THE RIGHT SIDE ON (B)(6) 2006. THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO UNK REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559789 DUROM ACETABULAR COMPONENT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2331001

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R