BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM 04.01.0130 HC PEGGED GLENOID Ø44

    MDR report key: 17956404 · Received October 18, 2023

    Report

    Report Number
    3005180920-2023-00811
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    September 11, 2023
    Report Date
    October 18, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713252
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-SEP-2023 . LOT 2103247: 26 ITEMS MANUFACTURED AND RELEASED ON 30-APR-2021. EXPIRATION DATE: 2026-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS UNKNOWN. AFTER REVIEWING X-RAYS, THE SURGEON NOTICED THAT THE GLENOID WAS NOT POSITIONED CORRECTLY. PARTICULARLY, THE SURGEON COMMENTED THAT HE DID NOT PUT THE GLENOID IN THE POSITION THAT HE WOULD HAVE PREFERRED DURING THE PRIMARY. THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619053 ANATOMICAL SHOULDER SYSTEM 04.01.0130 HC PEGGED GLENOID Ø44 SHOULDER HC PEGGED GLENOID KWS MEDACTA INTERNATIONAL SA 2103247 07630040713252

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention