BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER HEAD 40 12/14

    MDR report key: 4801146 · Received May 26, 2015

    Report

    Report Number
    9613350-2015-00617
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    September 3, 2014
    Report Date
    May 5, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, 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 AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS CPT(B)(4).

    Additional Manufacturer Narrative · 1

    A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICES WERE NOT AT HAND FOR INVESTIGATION. ROOT CAUSE ANALYSIS: THE CAUSE FOR THE REVISION SURGERY WAS FOUND TO BE THE BROKEN SCREW, NO PRIMARY INVOLVEMENT OF THE BIOLOX HEAD WAS MENTIONED IN THE SURGICAL REPORTS OR COULD BE SEEN IN THE RECEIVED X-RAY. FOR THE INVESTIGATION OF THE ACETABULAR SPIN OUT AND SCREW BREAKAGE, PLEASE REFER TO (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A BIOLOX DELTA CER HEAD 40 12/14 ON (B)(6) 2014 ON THE LEFT SIDE. IT WAS REPORTED THAT THE BIOLOX HEAD WAS EXPLANTED ON (B)(6) 2014 DUE TO PAIN AND DISLOCATION OF THE ACETABULAR COMPONENT CAUSED BY BROKEN SCREWS. NOTE: THE BROKEN SCREWS EVENT IS REPORTED IN (B)(4) (SPLIT CASE WITH ZIMMER WARSAW).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2015. IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO A DROPPED FOOT AND A LINER DISLOCATION CAUSED BY BROKEN SCREWS. ALONG WITH A LINER AND A CUP MANUFACTURED BY ZIMMER INC. ((B)(6)) A BIOLOX HEAD, ZIMMER INC. ((B)(6)) A BIOLOX HEAD, MANUFACTURED BY ZIMMER (B)(4) ((B)(6)) WAS REVISED. TWO X-RAYS A-P PELVIS WERE RECEIVED: ONE, DATED SEPTEMBER 2, 2014, SHOWED A PROXIMALLY DISLOCATED HIP. THE SECOND, DATED SEPTEMBER 4, 2014, SHOWED THE SITUATION AFTER THE REVISION WITH THE NEW IMPLANTS. NO OTHER INFORMATION RETRACTABLE DUE TO THE LOW QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339382 BIOLOX DELTA CER HEAD 40 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD KWA ZIMMER GMBH NA 2724128

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR