BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD 46

    MDR report key: 12098250 · Received July 1, 2021

    Report

    Report Number
    3005180920-2021-00528
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 1, 2021
    Report Date
    July 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713160
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 JUNE 2021: LOT 189736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-MAR-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENT HAS BEEN REPORTED FOR THIS LOT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 11 JUNE 2021: ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT 1902185: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2019. EXPIRATION DATE: 2024-JUN-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENT HAS BEEN REPORTED FOR THIS LOT. ANATOMICAL SHOULDER SYSTEM 04.01.0026 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 9 (K170910) LOT 1906624: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2019. EXPIRATION DATE: 2024-NOV-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENT HAS BEEN REPORTED FOR THIS LOT. ANATOMICAL SHOULDER SYSTEM 04.01.0133 HC PEGGED GLENOID Ø50 (K170910) LOT 184441: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-FEB-2019. EXPIRATION DATE: 2024-GEN-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENT HAS BEEN REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A FAILED SUBSCAPULARIS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HUMERAL HEAD, HUMERAL ANATOMIC METAPHYSIS, DOUBLE ECCENTER, AND HC PEGGED GLENOID. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996039 ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD 46 SHOULDER METALLIC HEAD KWS MEDACTA INTERNATIONAL SA 04.01.0093 189736 07630040713160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention