BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAD ADAPTER M/0; 12/14-18/20

    MDR report key: 5107688 · Received September 28, 2015

    Report

    Report Number
    9613350-2015-01088
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    November 1, 2013
    Report Date
    August 29, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2015. THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE COMPATIBILITY CHECK WAS PERFORMED FROM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. REVIEW OF INCOMING INFORMATION: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT RECEIVED AN IMPLANT ON (B)(6) 2010 AND WAS REVISED ON (B)(6) 2013 DUE TO PAIN, LIMITED RANGE OF MOTION, AND A LIMP THAT REQUIRED A CANE FOR AMBULATION. DURING THE REVISION SURGERY, THE SURGEON DISCOVERED "METAL-ON-METAL DEBRIS" WITHIN THE JIP JOINT. ADDITIONALLY, THEY ALLEGE SYNOVITIS WAS EXPOSED AND TREATED VIA A SYNOVECTOMY DURING THE REVISION SURGERY. NO X-- RAYS WERE PROVIDED. ONLY REVISION REPORT WAS PROVIDED FOR INVESTIGATION. THE QUALITY OF THE DOCUMENT IS EXTREMELY POOR AND VERY DIFFICULT TO READ POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFMEA # 91863, REV 6 INCREASED WEAR -> DUE TO CLEARANCE TOO SMALL - RIM LOADING. THIRD BODY WEAR -> DUE TO TI-VPS PARTICLES BETWEEN THE FEMORAL AND ACETABULAR COMPONENT. POSSIBLE AS NO PRODUCT AVAILABLE FOR ANALYSIS. NO SELF POLISHING - (RUN-IN PHASE) LEADS TO INCREASED WEAR -> DUE TO INADEQUATE ARTICULATION MATERIAL . POSSIBLE AS NO PRODUCT AVAILABLE FOR ANALYSIS. INCREASED NUMBER OF WEAR PARTICLES -> DUE TO CHEMICAL CORROSION. POSSIBLE AS NO PRODUCT AVAILABLE FOR ANALYSIS. REDUCED ROM, INCREASED WEAR -> DUE TO COMPONENT MALPOSITIONING. NO X-RAYS AVAILABLE FOR ANALYSIS. REDUCED ROM, INCREASED WEAR -> DUE TO COMPONENT MALPOSITIONING. NO X-RAYS AVAILABLE FOR ANALYSIS. INCREASED WEAR -> DUE TO COMPONENT DAMAGED DURING OPERATION - SCRATCHES ON ARTICULATION SURFACE. POSSIBLE AS NO PRODUCT AVAILABLE FOR ANALYSIS. INCREASED LOADING ON THE CUP, INCREASE WEAR AND FRICTION -> DUE TO INCREASED OR DECREASED OFFSET WHEN A LDH IS USED INSTEAD OF A SURFACE REPLACEMENT COMPONENT. NO X-RAYS AVAILABLE FOR ANALYSIS. INCREASED WEAR -> DUE TO COMPONENT DAMAGED DURING OPERATION - SCRATCHES ON ARTICULATION SURFACE. POSSIBLE AS NO PRODUCT AVAILABLE FOR ANALYSIS. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    A LEGAL CLAIM WAS RAISED. IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT RECEIVED A HEAD ADAPTER M/0; 12/14-18/20 PLANT ON (B)(6) 2010 AND WAS REVISED ON (B)(6) 2013 DUE TO PAIN, LIMITED RANGE OF MOTION, AND A LIMP THAT REQUIRED A CANE FOR AMBULATION. DURING THE REVISION SURGERY, THE SURGEON DISCOVERED "METAL-ON-METAL DEBRIS" WITHIN THE HIP JOINT. ADDITIONALLY, THEY ALLEGE SYNOVITIS WAS EXPOSED AND TREATED VIA A SYNOVECTOMY DURING THE REVISION SURGERY. INITIALLY IT WAS REPORTED JUST THE ZIMMER MMC CUP. ON (B)(6) 2015, ADDITIONAL INFORMATION WAS RECEIVED. THE STICKERS OF THE PRODUCTS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638982 HEAD ADAPTER M/0; 12/14-18/20 HEAD ADAPTER KWA ZIMMER GMBH 2506530

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R