BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS

    MDR report key: 15751575 · Received November 8, 2022

    Report

    Report Number
    3005180920-2022-00842
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040712651
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-OCT-2022: LOT 184527: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2018. EXPIRATION DATE: 2023-12-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. ADDITIONAL INFO REQUEST. BATCH REVIEW PERFORMED ON 28-OCT-2022: ANATOMICAL SHOULDER SYSTEM 04.01.0130 HC PEGGED GLENOID Ø44 (K170910) LOT 181488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2018. EXPIRATION DATE: 2023-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0092 METAL HUMERAL HEAD Ø44 (K170910) LOT 1710136: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2018. EXPIRATION DATE: 2023-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: REVISION 3 YEARS AND 4 MONTHS AFTER PRIMARY DUE TO PAIN AND DIFFICULTY WITH ROM AND, ACCORDING TO REPORT, THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT FROM ANATOMIC TO REVERSE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE ONLY RADIOGRAPHIC IMAGE PROVIDED AND THE GENERIC REPORT DO NOT RELEASE USEFUL INFORMATION. THEREFORE, NO FINAL CONCLUSIONS CAN BE GIVEN WITH THE INFORMATION AT HAND.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND DIFFICULTY WITH ROM AND THE CAUSE IS UNKNOWN. AT ABOUT 3 YEARS AND 4 MONTHS FROM PRIMARY THE SURGEON REVISED THE PATIENT FROM ANATOMIC TO REVERSE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377559 ANATOMICAL SHOULDER SYSTEM HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS SHOULDER ANATOMICAL METAPHYSIS KWS MEDACTA INTERNATIONAL SA 04.01.0027 184527 07630040712651

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention