BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCL BONE SCW TI 6.5MMX2

    MDR report key: 24443772 · Received February 25, 2026

    Report

    Report Number
    0001822565-2026-00612
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    K850770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; B5; D10; G3; H2; H6; H11. D10: MEDICAL PRODUCT: BURCH-SCHNEIDER, REINFORCEMENT CAGE, NEW, LEFT, 56: CATALOG #0100191156, LOT#3244799H2; CANCL BONE SCW TI 6.5MMX3: CATALOG #430107035, LOT#NI, QTY#3; CANCL BONE SCW TI 6.5MMX3: CATALOG #430107030, LOT#NI, QTY#2; CANCL BONE SCW TI 6.5MMX2: CATALOG #430107020, LOT#NI, QTY#1. THE INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: BURCH-SCHNEIDER, REINFORCEMENT CAGE, NEW, LEFT, 56: CATALOG#0100191156, LOT#3244799H2; CANCL BONE SCW TI 6.5MMX3: CATALOG#430107035, LOT#NI; CANCL BONE SCW TI 6.5MMX3: CATALOG#430107030, LOT#NI. G2: FOREIGN, (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, THE FIXATION SCREWS SLIPPED THROUGH THE HOLES IN THE SHELL COMPONENT. THERE WAS NO PATIENT IMPACT AS A RESULT AND THE FIXATION SCREWS REMAIN IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, THE FIXATION SCREWS SLIPPED THROUGH THE HOLES IN THE SHELL COMPONENT. INFORMATION REGARDING PATIENT IMPACT AND SUBSEQUENT INTERVENTION HAS NOT BEEN PROVIDED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503985 CANCL BONE SCW TI 6.5MMX2 SCREW, FIXATION, BONE HWC ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H11 NARRATIVE.| SEE H11 NARRATIVE.