BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46

    MDR report key: 15112258 · Received July 27, 2022

    Report

    Report Number
    3005180920-2022-00595
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    July 13, 2022
    Report Date
    July 27, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040719957
    PMA / PMN Number
    K181826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 JULY 2022 LOT 1908169: 62 ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2019. EXPIRATION DATE: 2024-DEC-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUTION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION PERFORMED 7 MONTHS AFTER THE PREVIOUS REVISION RSA DUE TO IMPLANT FAILURE IN A MALE PATIENT. ACCORDING TO REPORT, THE BASEPLATE MOBILIZED AND THAT MAY BE THE REASON WHY TWO POLYAXIAL SCREWS BROKE, AS VISIBLE IN THE RADIOGRAPHIC IMAGES. AN ALLOGRAFT WAS USED. IT IS POSSIBLE THAT THE ALLOGRAFT WAS NOT OSSEOINTEGRATED CAUSING THE MOBILIZATION OF THE BASEPLATE DURING SOME MOVEMENT OF THE ARM. FROM PREVIOUS REVISION, A FRAGMENT OF PREVIOUS SCREW REMAINED INSIDE THE PATIENT, WHICH LIKELY IT WAS NOT POSSIBLE TO REMOVE WITHOUT HARMING THE PATIENT. NO OTHER DETAILS ARE SPECIFIED REGARDING THE PREVIOUS REVISION. NO REASON TO SUSPECT A DEFECTIVE IMPLANT AT THE ORIGIN OF THIS ADVERSE EVENT. VISUAL INSPECTION PERFORMED BY R&D SHOULDER MANAGER: TWO POLYAXIAL SCREWS ARE CONFIRMED TO BE BROKEN AT ABOUT 30-35 MM FROM THE SCREW HEAD. THE BREAKAGE LIKELY OCCURRED IN BENDING FOLLOWING FAILURE OF THE BONE GRAFT AND IMPLANT MOBILIZATION. THE REMAINING EXPLANTS HAVE NO MAJOR SIGNS OF DAMAGE AND DO NOT SHOW ANY SCRATCHES OF PARTICULAR INTEREST. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 15 JULY 2022 REVERSE SHOULDER SYSTEM 04.01.0203 GLENOID POLYAXIAL NON-LOCKING SCREW - L50 (K181826) LOT. 187770 LOT 187770: 64 ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2019. EXPIRATION DATE: 2023-DEC-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0301 GRS BASEPLATE - Ø24.5X20 +3MM LOT. 2106796 (ITEM NOT REGISTERED IN USA) LOT 2106796: 64 ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2021. EXPIRATION DATE: 2026-NOV-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 7 MONTHS AFTER THE PREVIOUS REVISION SURGERY DUE TO BASEPLATE MOBILIZATION AND TWO POLYAXIAL SCREWS BREAKAGE (NO TRAUMA REPORTED). IT IS POSSIBLE THAT THE GLENOID COMPONENT WAS TOO LATERALIZED CAUSING OVERSTRESS AND SCREWS BREAKAGE. AN ALLOGRAFT WAS USED. THE PATIENT PREVIOUSLY HAD A REVISION ON 21.12.2021 DUE TO TRAUMA, DETAILS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431232 REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46 GLENOID POLYAXIAL NON-LOCKING SCREW PHX MEDACTA INTERNATIONAL SA 04.01.0202 1908169 07630040719957

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention