BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC SHOULDER PROSTHESIS

    MDR report key: 24964780 · Received April 23, 2026

    Report

    Report Number
    3005180920-2026-00356
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040712620
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 APRIL 2026 ANATOMICAL SHOULDER SYSTEM 04.01.0024 HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-7 (K170910) LOT 1910132: (B)(4) TEMS MANUFACTURED AND RELEASED ON 07-JUL-2020. EXPIRATION DATE: 21-JUN-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0090 METAL HUMERAL HEAD D 40 (K170910) LOT 2301922: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 22-OCT-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0128 HC PEGGED GLENOID D 40 (K170910) LOT 2309355: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-SEP-2023. EXPIRATION DATE: 04-SEP-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0180 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 7 (K180089) LOT 2335898: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 15-OCT-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249020 ANATOMIC SHOULDER PROSTHESIS HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-7 KWS MEDACTA INTERNATIONAL SA 04.01.0024 1910132 07630040712620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention