BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAPERLOC LAT COCR 10MM T1

    MDR report key: 24649262 · Received March 20, 2026

    Report

    Report Number
    3002806535-2026-00119
    Event Type
    Death
    Date Received
    March 20, 2026
    Date of Event
    August 21, 2024
    Report Date
    March 20, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    UDI-DI
    00887868350436
    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 28 X 44 MM; ITEM# 11-165212; LOT# 65737018 28 MM MOD HD STD NECK TP1 TAPER; ITEM# 163662; LOT# J7705882. 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 FIVE WEEKS FOLLOWING A RIGHT-SIDED HEMIARTHROPLASTY, THE PATIENT DIED TO 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
    708027 TAPERLOC LAT COCR 10MM T1 PROSTHESIS, HIP JDI BIOMET UK LTD. 7717047 00887868350436

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death SEE H11 NARRATIVE.