BEUDAMED
    FDA Adverse Event Death Summary report: N

    TPRLOC COCR CMTD STEM T1 7.5MM

    MDR report key: 24649276 · Received March 20, 2026

    Report

    Report Number
    3002806535-2026-00120
    Event Type
    Death
    Date Received
    March 20, 2026
    Date of Event
    July 13, 2022
    Report Date
    March 20, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    UDI-DI
    00887868350368
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: RINGLOC BI-POLAR 28X45MM; ITEM# 11-165214; LOT# 208430, 28MM MOD HD STD NECK TP1 TAPER; ITEM# 163662; LOT# 64850323. G2 - FOREIGN: THE 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 K050441. 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 APPROXIMATELY THREE WEEKS FOLLOWING A RIGHT-SIDED INITIAL HEMIARTHROPLASTY, THE PATIENT DIED DUE TO UNSPECIFIED CAUSES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708291 TPRLOC COCR CMTD STEM T1 7.5MM PROSTHESIS, HIP JDI BIOMET UK LTD. 7183169 00887868350368

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Death SEE H11 NARRATIVE.