BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM

    MDR report key: 14336300 · Received May 9, 2022

    Report

    Report Number
    3005180920-2022-00347
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 9, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 173417: 78 ITEMS MANUFACTURED AND RELEASED ON 27-JUNE-2017. EXPIRATION DATE: 2022-06-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 76 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENT SINCE (B)(6) 2018. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT. 174729 BATCH REVIEW PERFORMED ON 22 APRIL 2022: LOT 174729: 105 ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2017. EXPIRATION DATE: 2022-10-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 102 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT SINCE (B)(6) 2018.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION AS A RESULT OF MUSCULATURE LAXITY (NOT 2 IMPLANTS SEPARATING). AT 3 YEARS AND 5 MONTHS FROM THE PRIMARY THE SURGEON REMOVED THE GLENSOPHERE , BASEPLATE, METAPHYSIS AND INSERT. THE REVERSE METAPHYSIS WAS REPLACED WITH AN ANATOMICAL METAPHYSIS AND DOUBLE ECCENTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460093 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM REVERSE SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0119 173417 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention