BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE

    MDR report key: 23741734 · Received December 8, 2025

    Report

    Report Number
    0001825034-2025-03886
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 17, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304513129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6. G4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO 510(K) CAN BE DETERMINED. THE DEVICE IS CONSIDERED SIMILAR TO PRODUCT # 51-107170 AND 510(K) K110400. 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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT TOTAL HIP ARTHROPLASTY WITH ASYMMETRIC INCREASED FEMORAL OFFSET ON THE RIGHT COMPARED WITH THE LEFT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-0662 LOT# 3194550 DELTA CERAMIC FEM HD 36/+3MM. G2: FOREIGN ¿ AUSTRALIA. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION FOR LEG LENGTH SHORTENING AND OFFSET REDUCTION. THERE WAS OVER LENGTHENING DURING THE INITIAL PROCEDURE SO THERE WAS A REVISION TO CORRECT LEG LENGTH, CORRECT OFFSET, AND IMPROVE STABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143431 TAPERLOC COMPLETE PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 7905935 00880304513129

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Required Intervention| H