BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM FEMORAL COMPONENT 54 CODE T

    MDR report key: 4252942 · Received November 12, 2014

    Report

    Report Number
    9613350-2014-04104
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    September 8, 2008
    Report Date
    February 27, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KXA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICE OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE U.S., ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUP THAT RESULTED FROM USE OF SURGICAL TECHNIQUES NOT CONSISTENT WITH THE MANUFACTURER'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETRAINING PROGRAM FOR USERS OUTSIDE THE U.S. WAS INITIATED IN NOVEMBER 2009 AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE U.S. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE U.S. AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN JULY 2008 AS CORRECTION Z-2415/2426-2008. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE PROVIDED INFORMATION HAS BEEN MADE AVAILABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE COMPATIBILITY CHECK SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. REVIEW OF INCOMING INFORMATION: IT WAS REPORTED THAT A (B)(4) FEMALE PATIENT RECEIVED THE PRODUCT ON AN (B)(6) 2004 AND WAS REVISED ON (B)(6) 2009 DUE TO BROKEN FEMORAL PIN. REVIEW OF X-RAYS: X-RAY DATED (B)(6) 2008: A-P VIEW OF HIP PELVIS. PATIENT SHOWED A LEFT RESURFACING MOM PROSTHESIS WITH POTENTIAL BROKEN FEMORAL PIN. SLIGHT SIGS OF RADIOLUCENCY WERE VISIBLE AROUND THE PIN WHICH CANNOT BE 100% CONFIRMED. THE CUP SEEMED TO BE WELL FIXED IN THE ACETABULUM AND THE NO SIGNS OF LOOSENING WERE VISIBLE. ITS INCLINATION ANGLE OF WAS AROUND 45°. X-RAYS DATED (B)(6) 2008: A-P VIEW OF HIP PELVIS. PATIENT LEFT RESURFACING MOM PROSTHESIS HAS BEEN REVISED AND REPLACED BY THA AND LDH.. THE CUP SEEMED TO BE WELL FIXED IN THE ACETABULUM AND NO SIGNS OF LOOSENING WERE VISIBLE. ITS INCLINATION ANGLE WAS AROUND 45°. X-RAYS DATED (B)(6)2009: POST-REVISION X-RAYS. THE DUROM CUP HAS BEEN COMPLETELY REMOVED TOGETHER WITH THE LDH (TREATED IN REFERENCED COMPLAINTS (B)(4)) . NO OTHER CONSPICUOUS INFORMATION. REVIEW OF OP REPORT IS: IMPLANTATION REPORT DATED (B)(6) 2004: PATIENT UNDERWENT RESURFACING HIP ARTHROPLASTY DUE TO COXARTHROSIS. NO OTHER CONSPICUOUS INFORMATION. REVISION REPORT DATED (B)(6) 2009: PATIENT UNDERWENT REVISION DUE TO MECHANICAL COMPLICATION IN THE RESURFACING SYSTEM. NO OTHER CONSPICUOUS INFORMATION. DEVICE ANALYSIS: THE DEVICE ANALYSIS COULD NOT BE PERFORMED AS THE DEVICES WERE NOT RETURNED FOR INVESTIGATION. IT HAS TO BE ASSUMED THAT AT ONE POINT IN TIME IT CAME TO AN OVERLOAD OF THE SLIM STEM WHICH LED TO THE FATIGUE FRACTURE. THE SLIM STEM WAS AN ALIGNMENT DEVICE AND NOT DESIGNED TO TRANSMIT FORCE. A POSSIBLE REASONS FOR THE OVERLOAD OF THE SLIM STEM COULD BE A FEMORAL NECK FRACTURE OR A LOOSENING OF THE FEMORAL COMPONENT. IT WAS UNKNOWN IF THE SIGNS OF LOOSENING SEEN ON THE REMAINED BONE CEMENT DEVELOPED BEFORE OR AFTER THE FRACTURE OF THE SLIM STEM. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED TO ENTER ADDITIONAL INFORMATION WHICH HAD BEEN RECEIVED ON OCTOBER 05, 2015. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION, THERE WILL BE NO FURTHER INVESTIGATION. ZIMMER (B)(4) WILL CLOSE THIS CASE ONCE AGAIN. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 60/54 CODE T ON THE LEFT SIDE ON (B)(6) 2004. THE PT WAS REVISED ON (B)(6) 2009 DUE TO MECHANICAL PROBLEMS AND INCOMPATIBILITY BETWEEN FEMORAL AND ACETABULAR COMPONENT.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM FEMORAL COMPONENT 54 CODE T, IN COMBINATION WITH A DUROM ACETABULAR COMPONENT 60/54 CODE T ON (B)(6) 2004. THE PATIENT WAS REVISED ON (B)(6) 2008 DUE TO BREAKAGE OF THE FEMORAL PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729013 DUROM FEMORAL COMPONENT 54 CODE T DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS KXA ZIMMER GMBH NA 2106809

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R