BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 10

    MDR report key: 14591438 · Received June 3, 2022

    Report

    Report Number
    3005180920-2022-00441
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 3, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706049
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 MAY 2022: LOT 2006059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2020. EXPIRATION DATE: 2025-OCT-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 17 MAY 2022: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2003391: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2020. EXPIRATION DATE: 2025-OCT-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0152 GLENOID BASEPLATE Ø24.5X25 (K170452) LOT 2005435: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2020. EXPIRATION DATE: 2025-OCT-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT 2003842A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2020. EXPIRATION DATE: 2025-DEC-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT 2008850: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2020. EXPIRATION DATE: 2025-OCT-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0158 GLENOID POLYAXIAL LOCKING SCREW - L18 (K170452) LOT 1909106: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2019. EXPIRATION DATE: 2024-DEC-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT 2005659: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2020. EXPIRATION DATE: 2025-JUL-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA CLINICAL AFFAIRS SPECIALIST: LATE INFECTION IN RSA, 1 YEAR AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING RSA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, DUE TO LOW GRADE INFECTION (PATHOGEN UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586278 REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 10 SHOULDER UNCEMENTED DIAPHZSIS PHX MEDACTA INTERNATIONAL SA 04.01.0005 2006059 07630040706049

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention