BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27

    MDR report key: 18272871 · Received December 6, 2023

    Report

    Report Number
    3005180920-2023-00959
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 6, 2023
    Report Date
    January 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706599
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12-DECEMBER-2023 WE HAVE RECEIVED THE IMPLANTS VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: MILD CIRCUMFERENTIAL SIGNS ARE VISIBLE ON THE CONVEX BACKSURFACE OF THE GLENOSPHERE DUE TO FRICTION WITH AT LEAST ONE PERIPHERAL GLENOID SCREW. IT IS NOT POSSIBLE TO STATE WHETHER THE SCREW WAS POSITIONED PROUD FORM THE BASEPLATE AFTER THE PRIMARY SURGERY OR IT BACKED OUT IN THE FOLLOWING MONTHS. THE GLENOSPHERE SCREW SHOWS CIRCULAR SCRATCHES ON THE OUTER SURFACE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 NOVEMBER 2023 LOT 179112: 115 ITEMS MANUFACTURED AND RELEASED ON 26-MAR-2018. EXPIRATION DATE: 2023-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 101 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANALYSIS PERFORMED BY R&D MANAGER: THE PRESENCE OF RING MARKS ON THE GLENOSPHERE BACKSURFACE AND THE DAMAGE ON THE SCREW HEADS SUGGEST A CONTACT BETWEEN THE INVOLVED COMPONENTS. IT IS NOT POSSIBLE TO DETERMINE WHETHER THE SCREWS WERE POSITIONED PROUD FROM THE BASEPLATE DURING THE SURGERY OR THE SCREWS BACKED OFF LEADING TO CONTACT BETWEEN THE SCREWS AND THE GLENOSPHERE. NO ACTION IS SUGGESTED. OTHER COMPONENTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0156 GLENOID BASEPLATE Ø27X35 (K170452) LOT 183534: 50 ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2018. EXPIRATION DATE: 2023-07-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0158 GLENOID POLYAXIAL LOCKING SCREW - L18 (K170452) LOT 1811899: 150 ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 143 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 1811900: 160 ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 152 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT 1811901: 250 ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 246 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 182474: 378 ITEMS MANUFACTURED AND RELEASED ON 07-SEPT-2018. EXPIRATION DATE: 2023-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 363 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ONLY 2 OF THE 4 SCREWS IMPLANTED WERE DAMAGED BUT IT WAS NOT POSSIBLE TO KNOW WHICH ONES. THE BATCH REVIEW OF ALL SCREWS HAVE BEEN INCLUDED.

    Description of Event or Problem · 0

    AT 3 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND A LIMITED RANGE OF MOTION DUE TO DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. THE CAUSE OF THE DISSOCIATION IS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE SCREW RING MARKS ON THE BACK SIDE OF THE GLENOSPHERE, AND TWO POLYAXIAL SCREW HEADS WERE ALSO FOUND TO BE DAMAGED. A MILD DEGREE OF METALLOSIS WAS ALSO OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048773 REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 179112 07630040706599

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention