BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE

    MDR report key: 23188992 · Received October 1, 2025

    Report

    Report Number
    0001825034-2025-03065
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 110024464 LOT: 67220038 G7 DUAL MOBILITY LINER 44MM F. CAT: 650-1158 LOT: 3217174 DELTA CER FEM HD 28/0MM T1. G2: FOREIGN ¿ AUSTRALIA . G4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO 510(K) CAN BE DETERMINED. THE DEVICE IS CONSIDERED SIMILAR TO PRODUCT # 51-100050 AND 510(K) K103755. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) ¿ STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO FEMORAL BONE FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154483 TAPERLOC COMPLETE PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 7911963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R