BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE® GLENOID MODULAR CENTER POST REAMER

    MDR report key: 21009410 · Received December 23, 2024

    Report

    Report Number
    0001822565-2024-04053
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 2, 2024
    Report Date
    April 22, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K191814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ASSOCIATED PRODUCT INFORMATION, PART (LOT): - 110045821 (01746411). - 113032 (J7773112). - 118001 (66793040). - 405800 (67005526). - SAGL2043 (66737956). - SAGP0002 (66775282). - US-115734 (66511453). THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; E1; G1; G3; G6; H1; H2; H3; H6. PROPOSED ANNEX G CODE: MECHANICAL (G04) - DRILL. THE REPORTED EVENT IS CONFIRMED BY THE RETURNED DEVICE. VISUAL EXAMINATION OF THE RETURNED PRODUCT PICTURES IDENTIFIED THE DEVICE EXHIBITS SIGNS OF USE (SCRATCHES) AND CONFIRMING COMPLAINT THE TIP IS DAMAGED/CRACKED. PERFORMED DIMENSIONAL ANALYSIS RESULTS WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL SHOULDER ARTHROPLASTY, THE SURGEON INDICATED THAT THE DRILL BIT OF THE REAMER WAS DULL. THE CORRECT SURGICAL TECHNIQUE WAS USED, AND NO COMPLICATIONS, IMPACTS, OR SURGICAL INTERVENTIONS WERE REQUIRED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364465 ALLIANCE® GLENOID MODULAR CENTER POST REAMER INSTRUMENT - PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ZIMMER BIOMET, INC. NI 65768130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown H11