BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS STEM 145 DEGREE HAC

    MDR report key: 4749028 · Received May 1, 2015

    Report

    Report Number
    9613350-2015-00511
    Event Type
    Injury
    Date Received
    May 1, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 07/08/2015. AS THE CASE AT HAND IS A LEGAL CLAIM IT IS NOT SUSPECTED THAT THE DEVICE OR ADDITIONAL INFORMATION IS BEING SUBMITTED FOR REVIEW. NO TREND IDENTIFIED. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICES WERE NOT AT HAND FOR INVESTIGATION. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. WITHOUT ANY INFORMATION ABOUT THE EVENT, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE RISK FOR THE PATIENT. HOWEVER, THE POSSIBLE CAUSES FOR REVISION ARE COVERED IN THE DFMEA OF THE REPORTED DEVICE. 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

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED BY A SOLICITOR THAT THE PATIENT WAS IMPLANTED A CLS STEM 145 DEGREE HAC ON UNKNOWN SIDE ON (B)(6) 2006. IT WAS STATED THAT THE PATIENT WAS CLAIMING FOR DAMAGES FOR PERSONAL INJURIES AND ASSOCIATED LOSSES SUFFERED AS A RESULT OF THE POSSIBLE FAILURE OF HIS HIP PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289563 CLS STEM 145 DEGREE HAC CLS VARUS STEM/CLS 135 STEM KWL ZIMMER GMBH 2267642

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R