BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø46

    MDR report key: 8959608 · Received September 4, 2019

    Report

    Report Number
    3005180920-2019-00739
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    August 7, 2019
    Report Date
    September 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713269
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2019: LOT 182675: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2018. EXPIRATION DATE: 2023-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT. ANATOMICAL SHOULDER SYSTEM 04.01.0092 METAL HUMERAL HEAD Ø44 LOT. 1710137 (K170910) BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2019: LOT 1710137: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2018. EXPIRATION DATE: 2023-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER LOT. 185295 (K170910) BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2019: LOT 185295: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-DEC-2018. EXPIRATION DATE: 2023-11-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANATOMICAL SHOULDER SYSTEM 04.01.0027 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 10 LOT. 1710038, (K170910). BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2019: LOT 1710038: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2018. EXPIRATION DATE: 2023-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A TORN SUBSCAPULARIS MUSCLE. THE CAUSE OF THE TEAR IS UNKNOWN. THE SURGEON REMOVED THE HC PEGGED GLENOID, METAL HUMERAL HEAD, DOUBLE ECCENTER AND HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS AND IMPLANTED REVERSE SYSTEM IMPLANTS SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755647 ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø46 SHOULDER GLENOID KWS MEDACTA INTERNATIONAL SA 182675 07630040713269

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention