BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0

    MDR report key: 10122064 · Received June 5, 2020

    Report

    Report Number
    3005180920-2020-00308
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    May 5, 2020
    Report Date
    June 5, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 18 MAY 2020: LOT 174652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2018. EXPIRATION DATE: 26.02.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 175042: BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 18 MAY 2020: LOT 175042: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 07.09.2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0001 STD HUMERAL DIAPHYSIS - CEMENTLESS - 6 (K170452) LOT. 182479: BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 18 MAY 2020: LOT 182479: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2018. EXPIRATION DATE: 08.05.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT. 174728: BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 18 MAY 2020: LOT 174728: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2018. EXPIRATION DATE: 27.12.2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 (K171058) LOT. 185489: BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 18 MAY 2020: LOT 185489: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2018. EXPIRATION DATE: 21.08.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 182475: BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 18 MAY 2020: LOT 182475: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-SEP-2018. EXPIRATION DATE: 22.08.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 4 SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 182475. BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 18 MAY 2020 LOT 182475: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-SEP-2018. EXPIRATION DATE: 22.08.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 4 SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON DETERMINED THE GLENOID WAS LOOSE DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS, PERFORMED A WASHOUT AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585762 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0 REVERSE SHOULDER METAPHYSIS PHX MEDACTA INTERNATIONAL SA 04.01.0110 174652 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention