BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ASCEND FLEX STEM

    MDR report key: 20658110 · Received November 11, 2024

    Report

    Report Number
    3000931034-2024-00661
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    August 29, 2024
    Report Date
    January 28, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: H6 (DEVICE CODE GRID AND HEALTH IMPACT CODE GRID). THE REPORTED EVENT COULD BE CONFIRMED. THE DEVICE WAS NOT RETURNED BUT EVIDENCE WAS PROVIDED, BASED ON PROVIDED INFORMATION WHICH MATCH THE ALLEGED FAILURE. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE COMPLAINT EVENT DESCRIPTION STATED THAT THE HUMERAL SIDE WAS NOT ENOUGH CUT DURING SURGERY AND THE PATIENT HAD PAIN. FROM THIS INFORMATION PROVIDED, THE OPINION OF THE MEDICAL EXPERT WAS REQUESTED ON THIS CASE AND STATED AS FOLLOWS: IT IS KNOWN HOWEVER THAT A NON-ANATOMICAL RECONSTRUCTION OF THE SHOULDER IN SHOULDER HEMIARTHROPLASTY MAY LEAD TO EARLIER FAILURE BECAUSE OF ROTATOR CUFF DAMAGE. TOO MUCH TENSION ON THE ROTATOR CUFF IS NOT ONLY PAINFUL BUT ALSO KNOWN TO BE ASSOCIATED WITH EARLIER ROTATOR CUFF FAILURE (...). CONCLUSION: NONANATOMIC RECONSTRUCTION OF THE PROXIMAL HUMERUS IN HEMIARTHROPLASTY IS ASSOCIATED WITH LOWER FUNCTIONAL OUTCOMES, AS WELL AS HIGHER RISKS OF COMPLICATIONS AND REVISION. NON-ANATOMICAL RECONSTRUCTION IS A USER-RELATED ISSUE, HOWEVER, MAKES THE STEM AND HUMERAL HEAD PART OF THE EVENT. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED BY A NON-ANATOMICAL RECONSTRUCTION OF THE PROXIMAL HUMERUS IN SHOULDER HEMIARTHROPLASTY. 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. 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 A REVISION SURGERY TOOK PLACE AS THE SURGEON DIDN'T CUT ENOUGH ON THE HUMERAL SIDE AND THE PATIENT EXPERIENCED PAIN AS THE RESULT. THE PRIMARY SURGERY WAS A HEMI ARTHROPLASTY WITH ASCEND FLEX STEM & PYC. DURING THE REVISION, THE SURGEON USED THE SAME STEM AND CONVERTED IT IN REVERSE WITH PERFORM REV. IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE AS THE SURGEON DIDN'T CUT ENOUGH ON THE HUMERAL SIDE AND THE PATIENT EXPERIENCED PAIN AS THE RESULT. THE PRIMARY SURGERY WAS A HEMI ARTHROPLASTY WITH ASCEND FLEX STEM & PYC. DURING THE REVISION, THE SURGEON USED THE SAME STEM AND CONVERTED IT IN REVERSE WITH PERFORM REV. IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529970 UNKNOWN ASCEND FLEX STEM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention