BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM FLEX SIZE 3

    MDR report key: 20312733 · Received September 26, 2024

    Report

    Report Number
    3000931034-2024-00585
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 30, 2024
    Report Date
    December 20, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: PLEASE REFER TO SECTIONS B1 AND H6 (COMPONENT AND RESULTS CODES). THE REPORTED EVENT COULD BE CONFIRMED, SINCE X-RAYS WERE PROVIDED FOR INVESTIGATION. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. SINCE X-RAYS WERE PROVIDED, THE OPINION OF THE MEDICAL EXPERT WAS REQUESTED AND STATED AS FOLLOWING: THE X-RAY INDEED SHOW A NON-CENTERED PYCHH. IN RELATION TO THE GLENOID THE HUMERAL HEAD IS OFF-CENTER IN A SUPERIOR AND A POSTERIOR DIRECTION. PREOPERATIVE IMAGING WOULD BE HELPFUL TO DETERMINE THE PATIENT¿S GLENOID ANATOMY. ALSO, INFORMATION AS TO WHY THIS YOUNG PATIENT (BELOW THE AGE OF 30 YEARS) DEVELOPED GLENOHUMERAL OSTEOARTHRITIS WOULD BE HELPFUL. THE IMPLANT IS INTACT, WELL-FIXED AND HAS AN ACCEPTABLE POSITION. SUFFICIENT (RADIOLOGICAL AND CLINICAL) INFORMATION MUST BE PROVIDED TO ENABLE A MEANINGFUL CLINICAL ASSESSMENT AND TO IDENTIFY POSSIBLE CAUSES OF FAILURE. IN CASES WHERE NO SUCH INFORMATION IS AVAILABLE, THIS ASSESSMENT IS LIMITED. NO CONCLUSIVE STATEMENT CAN BE PROVIDED, BECAUSE KEY CLINICAL INFORMATION (E.G. CLINICAL STATUS, EXACT SYMPTOMS AND RANGE OF MOTION OF THE PATIENT, ASSESSMENT OF THE TREATING PHYSICIAN) IS MISSING. DUE TO THESE LIMITATIONS, I AM UNABLE TO PROVIDE STATEMENTS ABOUT THE PATIENT, THE PROCEDURE, AND/OR THE DEVICE IN RELATION TO CAUSE OF THE FAILURE. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE CATALOG NUMBER AND LOT NUMBER WERE NOT COMMUNICATED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT : "ON FRIDAY (B)(6) I ATTENDED A TORNIER PYROCARBON HUMERAL HEAD IMPLANT REVISION. EXPLANTED PROSTHESIS: PYC HUMERAL HEAD MODEL DWH038 SERIAL NUMBER (B)(6) AND STEM FLEX SIZE 3. DATE OF IMPLANTATION (B)(6) 2022. PROSTHESIS REPLACED BY A PERFORM REVERSED, STEM SIZE 1+, AND A LOW PROFILE POLY INSERT. EXPLANATION OF THE CASE : PATIENT HAD HER HUMERAL SYSTEMATICALLY HALF LUXATED IN POSTERIOR, WITHOUT BEING A B2 (SURGEON SAID IT WAS A ¿TRICKY ANATOMY¿). PYC HEAD WAS A TENTATIVE OF TREATMENT, HOPING FOR SOME ¿SPONTANEOUS RECENTRATION¿ THANKS TO PYC MATERIAL. NO REAMING NOR MICRO-PERFORATION HAD BEEN DONE ON THE GLENOID SIDE. PATIENT WAS PERMANENTLY WITH PAIN. AFTER PYC IMPLANTATION, PATIENT WENT PAIN FREE FOR ABOUT 9 MONTH, BUT THEN WENT BACK TO PAIN. NO RECENTRATION OCCURED AND HUMERAL HEAD STAYED HALF LUXATED IN POSTERIOR. SO SURGEON DECIDED TO REPLACE BY A REVERSED. NOTE THAT X RAY PROVIDED SHOWS PROSTHESIS VERY HIGH, BUT IT WASN¿T THE CASE : THE FACT WAS THAT THE IMPLANT WAS LUXATED IN POSTERIOR, THAT GIVES TO LOOK LIKE IT WAS TO HIGH BUT WASN¿T THE CASE. SURGEON DECIDED TO NOT KEEP THE FLEX STEM, BECAUSE FLEX REVERSED IS INLAY, AND IS KNOWN THE GENERATE A HIGH PRESSURE (BY LATERALIZATION). HE PREFERRED TO USE A PERFORM WHICH IS INLAY, SO GENERATES LESS PRESSURE. SINCE PATIENT IS YOUNG AND PAINFULL, HE CONSIDERED LESS PRESSURE WILL BE BETTER. IN CONCLUSION THE SURGEON SAYS THE PYC PROSTHESIS IS NOT RESPONSIBLE OF THE REVISION. DIFFICULT ANATOMY OF THE PATIENT MADE THAT PYC HEMI PROSTHESIS WASN¿T APPROPRIATE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT : "ON FRIDAY (B)(6), I ATTENDED A TORNIER PYROCARBON HUMERAL HEAD IMPLANT REVISION. EXPLANTED PROSTHESIS: PYC HUMERAL HEAD MODEL DWH038 SERIAL NUMBER (B)(6) AND STEM FLEX SIZE 3. DATE OF IMPLANTATION (B)(6) 2022. PROSTHESIS REPLACED BY A PERFORM REVERSED, STEM SIZE 1+, AND A LOW PROFILE POLY INSERT. EXPLANATION OF THE CASE : PATIENT HAD HER HUMERAL SYSTEMATICALLY HALF LUXATED IN POSTERIOR, WITHOUT BEING A B2 (SURGEON SAID IT WAS A ¿TRICKY ANATOMY¿). PYC HEAD WAS A TENTATIVE OF TREATMENT, HOPING FOR SOME ¿SPONTANEOUS RECENTRATION¿ THANKS TO PYC MATERIAL. NO REAMING NOR MICRO-PERFORATION HAD BEEN DONE ON THE GLENOID SIDE. PATIENT WAS PERMANENTLY WITH PAIN. AFTER PYC IMPLANTATION, PATIENT WENT PAIN FREE FOR ABOUT 9 MONTH, BUT THEN WENT BACK TO PAIN. NO RECENTRATION OCCURED AND HUMERAL HEAD STAYED HALF LUXATED IN POSTERIOR. SO SURGEON DECIDED TO REPLACE BY A REVERSED. NOTE THAT X RAY PROVIDED SHOWS PROSTHESIS VERY HIGH, BUT IT WASN¿T THE CASE : THE FACT WAS THAT THE IMPLANT WAS LUXATED IN POSTERIOR, THAT GIVES TO LOOK LIKE IT WAS TO HIGH BUT WASN¿T THE CASE. SURGEON DECIDED TO NOT KEEP THE FLEX STEM, BECAUSE FLEX REVERSED IS INLAY, AND IS KNOWN THE GENERATE A HIGH PRESSURE (BY LATERALIZATION). HE PREFERRED TO USE A PERFORM WHICH IS INLAY, SO GENERATES LESS PRESSURE. SINCE PATIENT IS YOUNG AND PAINFULL, HE CONSIDERED LESS PRESSURE WILL BE BETTER. IN CONCLUSION THE SURGEON SAYS THE PYC PROSTHESIS IS NOT RESPONSIBLE OF THE REVISION. DIFFICULT ANATOMY OF THE PATIENT MADE THAT PYC HEMI PROSTHESIS WASN¿T APPROPRIATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739575 UNKNOWN STEM FLEX SIZE 3 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention