BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM FEMORAL COMPONENT

    MDR report key: 5301080 · Received December 16, 2015

    Report

    Report Number
    9613350-2015-02013
    Event Type
    Injury
    Date Received
    December 16, 2015
    Date of Event
    June 5, 2012
    Report Date
    November 19, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. TREND ANALYSIS: TREND ANALYSIS COULD NOT BE PERFORMED AS NO REFERENCE NUMBER WAS AVAILABLE. COMPATIBILITY CHECK: THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS NO PRODUCT INFORMATION WAS PROVIDED. REVIEW OF INCOMING INFORMATION A LEGAL CLAIM WAS RISED. THE PRODUCT WAS IMPLANTED ON (B)(6) 2012 REVISED ON (B)(6) 2012 DUE TO UNKNOWN REASONS. DEVICES ANALYSIS DEVICE ANALYSIS COULD NOT BE PERFORMED AS NO PRODUCT WAS AVAILABLE FOR INVESTIGATION NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN DFMEA. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES IN (B)(4). THIS INFORMATION WAS REPORTED IN ERROR ON FOLLOW UP 0009613350-2015-02013-2 SENT ON 04/14/2016.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A LEGAL CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM FEMORAL COMPONENT ON (B)(6) 2015 . WE WERE INFORMED THAT HIS INITIAL HIP REPLACEMENT WAS A RESURFACING APPLICATION (IMPLANTED (B)(6) 2012) WHICH WAS CONVERTED TO A TOTAL HIP REPLACEMENT ON (B)(6) 2012. THE ALLEGATION IS AGAINST THE MMC CUP WHICH IS REPORTED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830240 DUROM FEMORAL COMPONENT DUROM FEMORAL COMPONENT KWA ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R