BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GRS BASEPLATE - Ø24.5X20 +6MM

    MDR report key: 19603233 · Received June 25, 2024

    Report

    Report Number
    3005180920-2024-00466
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    April 19, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630345710314
    PMA / PMN Number
    K213459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 7 JUNE 2024 LOT 2205361: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2022. EXPIRATION DATE: 2027-OCT-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT REVISION 1 YEAR AND 2 MONTHS AFTER PRIMARY RSA, DUE TO RECURRENT LUXATION AND GLENOID BASEPLATE LOOSENING. A BONE GRAFT WAS USED AND IT MAY BE POSSIBLE THAT THE GRAFT WAS NOT OSTEOINTEGRATED AND CAUSED THE LOOSENING. THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. ADDITIONAL INVOLVED IMPLANTS BATCH REVIEW PERFORMED ON 7 JUNE 2024 ON REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - Ø36X24.5 (K170452) LOT. 2201462 LOT 2201462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2022. EXPIRATION DATE: 2027-MAY-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 7 JUNE 2024 ON REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 2215133 LOT 2215133: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2022. EXPIRATION DATE: 2027-OCT-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    PRIMARY SURGERY ON (B)(6) 2023 AFTER A TONIC CLONIC SEIZURE WITH POSTERIOR LUXATIONS ON BOTH THE LEFT AND RIGHT SHOULDER ON (B)(6) 2023. BONE GRAFTS USED. REVISION SURGERY PERFORMED ON (B)(6) 2024 AFTER RECURRENT SHOULDER LUXATIONS ON THE RIGHT SIDE AND GLENOID BASEPLATE LOOSENING. CHANGE OF BASEPLATE, SCREWS, GLENOSPHERE AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208504 REVERSE SHOULDER SYSTEM GRS BASEPLATE - Ø24.5X20 +6MM SHOULDER REVERSE SYSTEM BASEPLATE PHX MEDACTA INTERNATIONAL SA 2205361 07630345710314

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention