BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27

    MDR report key: 8310191 · Received February 6, 2019

    Report

    Report Number
    3005180920-2019-00022
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    January 9, 2019
    Report Date
    February 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706605
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 FEBRUARY 2019: LOT 174737: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2018. EXPIRATION DATE: 2022-12-27. 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. ADDITIONAL IMPLANT REVISED: REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452) LOT 173458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUN-2017. EXPIRATION DATE: 2022-05-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED THAT THE PATIENT NEEDED A REVISION 4 MONTHS AFTER IMPLANTATION FOR A RECIDIVIST DISLOCATION: ON (B)(6) 2019 THE SURGEON REVISED SUCCESSFULLY THE PATIENT SHOULDER SWAPPING THE GLENOSPHERE AND THE INLAY . THE GLENOSPHERE HAD LUXATED FROM THE INLAY. THE GLENOSPHERE WAS CHANGED FROM 36 TO 42 AND THE INLAY FROM 36 TO 42 +6MM. Y. THE PATIENT NOT LEADABLE, MAYBE ALCOHOL DRUG OR SIMILAR. THE PATIENT HAD ALREADY HAD THE FOLLOWING SURGERIES; SURGERY 25.4.2018 RTSA (REVERSE TOTAL SHOULDER ARTHROPLASTY) AFTER PROX. HUMERUS FX; SURGERY 15.6.2018 REVISION RTSA HUMERUSDIAPHYSE +9, AFTER LUXATION-->COMPLAINT (B)(4) (MDR 2018-000761); SURGERY 27.8.2018 REVISION RTSA HIGER LINER HEAD 42MM, AFTER LUXATIONY-->COMPLAINT (B)(4) (MDR 2018-000760); REVISION SURGERY DUE TO INFECTION 2 WEEKS AFTER THE PREVIOUS SURGERY->COMPLAINT (B)(4) (MDR 2018-000757).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103005 REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 REVERSE SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 174737 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention