BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM INSTRUMENT

    MDR report key: 20961681 · Received December 18, 2024

    Report

    Report Number
    3005180920-2024-01060
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 20, 2024
    Report Date
    March 11, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS COMPLAINT, AS REPORTED IN THE EVENT DESCRIPTION, THE PACKAGING OF A DEVICE WAS FOUND BROKEN. THE DEVICE INVOLVED IS: REVERSE SHOULDER SYSTEM 04.01.0003 STD HUMERAL DIAPHYSIS - CEMENTLESS - 8 (K170910) LOT. 2202554. BELOW THE ANALYSIS PERFORMED REGARDING THIS DEVICE: BATCH REVIEW PERFORMED ON 27 NOV 2024: LOT 2202554: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2022. EXPIRATION DATE: 2027-03-22. 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. PICTURE ANALYSIS PERFORMED BY PACKAGING AND WASHING MANAGER. THE COMPLAINT HIGHLIGHTS THE PERFORATION BY THE IMPLANT OF THE PLASTIC BAG. THE BREAKAGE COULD HAVE BEEN GENERATED DURING HANDLING/TRANSPORT. THE PACKAGING USED FOR THIS BATCH HAS BEEN IMPROVED.

    Description of Event or Problem · 0

    DURING THE PRIMARY SHOULDER SURGERY, THE SURGEON PLANNED TO UTILIZE A STANDARD SIZE 8 STEM BUT THE INNER PACKAGING WAS BROKEN AND THE STEM PROTRUDED. THERE WAS NO ANOTHER STANDARD SIZE 8 STEM AVAILABLE, SO THE SURGEON DOWNSIZED TO A SIZE 7, WHICH WAS UNSTABLE. THE SURGEON THEN ATTEMPTED TO UPSIZE TO A STANDARD SIZE 9 STEM BUT THE CALCAR FRACTURED DURING BROACHING. THE SURGEON ULTIMATELY DECIDED TO IMPLANT A LONG SIZE 8 STEM. DUE TO THIS, THE SURGERY WAS EXTENDED BY APPROXIMATELY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720497 SHOULDER SYSTEM INSTRUMENT HUMERAL STANDARD BROACH - Ø9 LXH MEDACTA INTERNATIONAL SA 04.01.10.0020 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other