BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, 46-16

    MDR report key: 17441502 · Received August 2, 2023

    Report

    Report Number
    0009613350-2023-00432
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    July 3, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSD
    UDI-DI
    00889024415942
    PMA / PMN Number
    K171858
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: SWITZERLAND. D10: ASSOCIATED PRODUCTS: ITEM REFERENCE:01.04440.013, ITEM NAME:ANAVERSE¿ GLENOID, LINER, M, HUMERAL HEAD, 46-16, ITEM LOT:2977500. ITEM REFERENCE:01.04440.033, ITEM NAME:DPSC SCREW, 33MM 46-16, ITEM LOT:2994817. ITEM REFERENCE:01.04440.036, ITEM NAME:DPSC SCREW, 36MM, 46-16, ITEM LOT:2994818. ITEM REFERENCE:01.04555.120, ITEM NAME:SIDUS® STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, M, 46-16, ITEM LOT:2960619. ITEM REFERENCE:01.04440.003, ITEM NAME:ANAVERSE¿ GLENOID, BASEPLATE, M, 15MM, 46-16, ITEM LOT:2994240. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPON REVIEW OF THIS COMPLAINT FROM AN INVESTIGATION PERSPECTIVE, IT IS NOW CONSIDERED THAT THE SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, WITHIN THIS COMPLAINT DOES NOT IMPACT THE REPORTED EVENT OF LINER FRACTURE AND DISLOCATION. GIVEN THE ABOVE INFORMATION THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WITH TOTAL SHOULDER PROSTHESIS HAS BEEN REVISED FOUR (4) YEARS AFTER INITIAL SURGERY DUE TO PAIN, LINER FRACTURE AND DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    UPON REVIEW OF THIS COMPLAINT FROM AN INVESTIGATION PERSPECTIVE, IT IS NOW CONSIDERED THAT THE SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, WITHIN THIS COMPLAINT DOES NOT IMPACT THE REPORTED EVENT OF LINER FRACTURE AND DISLOCATION. HENCE THIS REPORT WILL BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773495 SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, 46-16 SHOULDER PROSTHESIS HSD ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2980304 00889024415942

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R