BEUDAMED
    FDA Adverse Event Death Summary report: N

    TPRLOC COCR CMTD STM T1 12.5MM

    MDR report key: 24659945 · Received March 23, 2026

    Report

    Report Number
    3002806535-2026-00126
    Event Type
    Death
    Date Received
    March 23, 2026
    Date of Event
    June 20, 2022
    Report Date
    March 20, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    UDI-DI
    00887868350382
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024281059. D10: ITEM NAME# DELTA CER FEM HD 28/0MM T1; ITEM NUMBER# 650-1158; LOT NUMBER# 3103748. ITEM NAME# RINGLOC BI-POLAR 28X52MM; ITEM NUMBER# 11-165228; LOT NUMBER# 668200. G2: FOREIGN - EVENT OCCURRED IN NETHERLANDS. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K192236. 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 THE PATIENT DIED APPROXIMATELY THREE WEEKS AFTER A HEMIARTHROPLASTY DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723710 TPRLOC COCR CMTD STM T1 12.5MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI BIOMET UK LTD. 7187144 00887868350382

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death SEE H11 NARRATIVE