BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27

    MDR report key: 18198434 · Received November 23, 2023

    Report

    Report Number
    3005180920-2023-00914
    Event Type
    Injury
    Date Received
    November 23, 2023
    Date of Event
    October 25, 2023
    Report Date
    December 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706605
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D MANAGER: THE OUTER CHAMFER OF THE LINER SHOWS CIRCULAR SCRATCHES ON THE THIN SIDE OF THE LINER THAT MAY HAVE BEEN CAUSED BY FRICTION WITH THE SCAPULAR NECK. IT IS NOT POSSIBLE TO DETERMINE WHETHER ANY EARLY IMPINGEMENT MAY HAVE LED TO INSTABILITY PHENOMENA AND THEREFORE TO JOINT LUXATION. IN ADDITION, THE GLENOSPHERE HAS A PARTIAL DISCOLORATION ON THE ARTICULAR SURFACE, LIKELY DUE TO FRICTION WITH THE HUMERAL METAPHYSIS AFTER JOINT LUXATION. NO ACTION IS SUGGESTED.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03-NOV-2023: LOT 2240240: 60 ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2022. EXPIRATION DATE: 2027-11-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 03-NOV-2023: REVIEW FOR REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT 2217118: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2022. EXPIRATION DATE: 2027-09-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 55 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: REVISION 7 MONTHS AFTER INDEX SURGERY RSA DUE TO JOINT LUXATION. THESE EVENTS ARE NORMALLY ORIGINATED BY PROGRESSION OF DISEASE TO THE SOFT TISSUES OR INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. FROM THE RADIOGRAPHIC IMAGES NO ADDITIONAL INFO CAN BE FOUND. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO JOINT LUXATION, AT ABOUT 7 MONTHS AFTER PRIMARY. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY REVISING THE LINER AND THE GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229752 REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 2240240 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention