BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXAFIT T4.1

    MDR report key: 5212158 · Received November 9, 2015

    Report

    Report Number
    9613350-2015-01667
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    September 10, 2015
    Report Date
    October 23, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN EXAFIT T4.1 (B)(6), 2001. SHE FELL IN THE STREET AND THEREAFTER SHE WAS FEELING PAIN AT THE LEVEL OF HIS RIGHT HIP. AFTER X-RAY ANALYSIS (NOT RETURNED FOR INVESTIGATION) IT WAS NOTICED THAT A FRACTURE OCCURRED IN THE FEMORAL NECK. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015. NO TREND WAS IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. IMPLANTATION REPORT DATED (B)(6), 2001: PATIENT UNDERWENT RIGHT THA DUE TO COXARTHROSIS. CUP POSITIONED AT 40° INCLINATION ANGLE AND 20° ANTIVERSION ANGLE. NO OTHER CONSPICUOUS INFORMATION. REVISION REPORT DATED (B)(6), 2015: PATIENT HAD A FATIGUE FRACTURE AT THE LEVEL OF STEM NECK OF RIGHT THA. CERAMIC ALUMINA HEAD, PE LINER AND EXAFIT STEM WERE REMOVED. PROTASUL HEAD AND PE LONGEVITY LINER WERE IMPLANTED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE: THE GEOMETRY OF THE NECK AROUND THE IMPACTION HOLE LED TO A HIGH STRESS CONCENTRATION ON ONE OR BOTH SIDES OF THE HOLE, RESULTING IN A FATIGUE FAILURE OF THE IMPLANT. ZIMMER RECOGNIZED THIS DESIGN ISSUE AND ACTIONS WERE TAKEN BY MODIFYING THE SHAPE OF THE IMPACTION HOLE. THE PART WAS PRODUCED BEFORE THE DESIGN CHANGE WAS IN PLACE. IN EARLY (B)(6) 2003, ZIMMER INITIATED A DESIGN CHANGE INCLUDING A MODIFICATION OF THE IMPACTION HOLE TO ALLOW THE USE OF A STANDARD INSTRUMENTATION FOR IMPACTION AND EXTRACTION. THIS RESULTED IN THE INTRODUCTION OF A NEW DESIGN OF THE EXAFIT STEM IN (B)(6) 2003. ALSO DURING THE SAME YEAR 2003, THERE WAS A REPORT IN FEBRUARY 2003 OF BREAKAGE OF THE EXAFIT STEM IN (B)(6) 2003. THE ROOT CAUSE OF THE BREAKAGE WAS DETERMINED TO BE AN IMPACTION HOLE WHICH RESULTED IN A NOTCH EFFECT. THE DESIGN CHANGE TO THE EXAFIT STEM DESCRIBED ABOVE ADDRESSED THE ROOT CAUSE OF THE REPORTED EVENT AT HAND AND THEREFORE NO FURTHER CORRECTIVE ACTION IS REQUIRED. THE PART OF THE CASE AT HAND WAS PRODUCED BEFORE THE DESIGN CHANGE WAS IN PLACE. ZIMMER WILL CONSIDER THIS INVESTIGATION AS CLOSED, BUT WILL CONTINUE MONITORING FOR SIMILAR INCIDENTS. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS A WRONG LOT NUMBER WAS 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. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E MS-STEM) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. 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

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED AN EXAFIT T4.1 ON (B)(6), 2001.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN EXAFIT STEM ON THE RIGHT SIDE ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND THAT HE FELL ON THE STREET ON (B)(6), 2015. IT WAS REPORTED THAT X-RAYS SHOWED A BREAKAGE OF THE PROSTHESIS FEMORAL NECK. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6), 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740908 EXAFIT T4.1 UNKNOWN LZO ZIMMER GMBH NA L0325.12

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R