BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 22X15

    MDR report key: 12597642 · Received October 8, 2021

    Report

    Report Number
    3005180920-2021-00796
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706353
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 OCTOBER 2021. LOT 2012464: 30 ITEMS MANUFACTURED AND RELEASED ON 20-APR-2021 . EXPIRATION DATE: 2026-04-06. 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. CLINICAL EVALUATION: FEW DAYS AFTER PRIMARY RSA THE JOINT DISLOCATES AND THE GLENOID BONE IS FOUND FRACTURE AT CT SCAN. IT WAS NOT POSSIBLE TO DETERMINE IF THE CONDITION HAD BEEN DETERMINED BY TRAUMA, BECAUSE THE PATIENT IS DEMENTED AND CANNOT CONFIRM. THE MOBILIZED BASEPLATE WAS REMOVED AND THE REVERSE PROSTHESIS CHANGED TO ANATOMIC, WITH NO GLENOIDAL IMPLANT. NO REASON TO SUSPECT A DEVICE DEFICIENCY AT THE ORIGIN OF THIS PROBLEM. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 04 OCTOBER 2021: REVERSE SHOULDER SYSTEM 04.01.0117 HUMERAL REVERSE HC LINER ¿32/+3MM (K170452)LOT 179976: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APR-2018. EXPIRATION DATE: 2023-04-09. 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. REVERSE SHOULDER SYSTEM 04.01.0167 GLENOSPHERE 32X¿22 (K170452) LOT 189859A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JAN-2021. EXPIRATION DATE: 2026-01-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LOT 189859A DERIVES FROM LOT 189859: LOT 189859: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2019. EXPIRATION DATE: 2024-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO ITEMS OF THE SAME LOT HAVE BEEN SOLD. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452)LOT. 2010930: LOT 2010930: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2021. EXPIRATION DATE: 2025-12-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 57 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT A SIMILAR REPORTED EVENT. NOTE THAT TWO DEVICES WITH THE SAME LOT NUMBER WERE REPORTED IN THIS CASE.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2021 AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. DUE TO SUSPICION OF HEMATOMA, THE SURGEON TOOK A CT SCAN AND NOTICED AN ABNORMALITY IN THE GLENOID FOSSA. DURING THE COURSE OF REVISION SURGERY, THE SURGEON NOTICED GLENOID FRACTURE AND DISLOCATION OF THE BASE PLATE. GLENOID IMPLANTS WERE ALL REMOVED. THE HUMERAL LINER AND TRAY WERE REPLACED WITH AN ANATOMICAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS DEMENTIA, IT IS UNKNOWN IF THERE WAS A TRAUMATIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493427 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 22X15 GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0148 2012464 07630040706353

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention