BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC COCR 10X140MM 12/14

    MDR report key: 24648116 · Received March 20, 2026

    Report

    Report Number
    3002806535-2026-00117
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    September 26, 2022
    Report Date
    March 19, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    UDI-DI
    05019279680559
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    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: G7 BISPHERICAL SHELL 54F; ITEM# 110017333; LOT# 6705273. G7 10 DEG E1 LINER 36MM F; ITEM# 010000897; LOT# 6786217. DELTA CER FM HD 036/+4MM 12/14; ITEM# 650-0838; LOT# 2019030443. G2 - FOREIGN: SWITZERLAND. 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 THE PATIENT HAD AN INITIAL RIGHT HIP ARTHROPLASTY AT AN UNKNOWN DATE. SUBSEQUENTLY, THEY UNDERWENT A REVISION SURGERY DUE TO FEMORAL IMPLANT LOOSENING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715869 TPRLC COCR 10X140MM 12/14 PROSTHESIS, HIP JDI BIOMET UK LTD. 6545582 05019279680559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.