BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER HRS SPACER 15MM DIA 20MM LENGTH

    MDR report key: 19986121 · Received August 14, 2024

    Report

    Report Number
    0001649390-2024-00364
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    June 1, 2024
    Report Date
    October 16, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    00846832092611
    PMA / PMN Number
    K181420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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 DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    PATIENT: (B)(6) - FLEX REVIVE STUDY. ADVERSE EVENT DETAIL: POST-OPERATIVE COMPLICATION: INCREASED PAIN AND STIFFNESS OF RIGHT SHOULDER. PATIENT HAS NO REDNESS OR SWELLING. ABNORMAL LABS (B)(6) 2024: CRP, ESR, CBC (HGB, HCT, RDW) AS WELL AS UNDERLYING DEGENERATIVE DISK DISEASE OF THE CERVICAL SPINE. TREATMENT/MEDICATION: PREDNISONE 5MG FOR 15 DAYS.

    Description of Event or Problem · 0

    PATIENT: (B)(6) - FLEX REVIVE STUDY. ADVERSE EVENT DETAIL: POST-OPERATIVE COMPLICATION: INCREASED PAIN AND STIFFNESS OF RIGHT SHOULDER. PATIENT HAS NO REDNESS OR SWELLING. ABNORMAL LABS (B)(6) 2024: CRP, ESR, CBC (HGB, HCT, RDW) AS WELL AS UNDERLYING DEGENERATIVE DISK DISEASE OF THE CERVICAL SPINE. TREATMENT/MEDICATION: PREDNISONE 5MG FOR 15 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349587 TORNIER HRS SPACER 15MM DIA 20MM LENGTH PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. AZ0621078 00846832092611

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention