BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 52/46 CODE L

    MDR report key: 2243783 · Received September 1, 2011

    Report

    Report Number
    9613350-2011-00579
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    January 15, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, 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. 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 ADDITIONAL 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 REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON (B)(4) 2018 TO ENTER ADDITIONAL INFORMATION WHICH WAS RECEIVED ON (B)(4) 2018. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION WHICH WAS REPORTED TO THE FDA IN (B)(4) 2008 AS CORRECTION Z-2415/2426-2008, THERE WILL BE NO FURTHER INVESTIGATION AND ZIMMER GMBH WILL CLOSE THIS CASE ONCE AGAIN. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT TOTAL HIP ARTHROPLASTY IN 2006. THE PT WAS REVISED IN 2010 DUE TO THE LOOSENING.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 52/46 CODE L ON THE RIGHT SIDE ON (B)(6) 2006. THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 52/46 CODE L DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH N/A 2309477

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R