BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

    MDR report key: 17876933 · Received October 4, 2023

    Report

    Report Number
    MW5146596
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    January 1, 2000
    Report Date
    October 4, 2023
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING, STATING SHE HAS PROBLEMS WITH CHRONIC PAIN AND NERVE DAMAGE AS A RESULT OF THREE HIP SURGERIES. REPORTER STATES "I DON'T WANT TO GO THROUGH ANOTHER HIP IMPLANT AGAIN" DUE TO THESE PROBLEMS, AND EXPRESSES CONCERN IF THE BIOMET HIPS ARE POSSIBLY UNDER RECALL. REPORTER STATES SHE PREVIOUSLY RETURNED ONE OF THE HIPS TO THE MANUFACTURER "FOR EVALUATION" BUT THEY HAVE NEVER CONTACTED HER BACK. "LOT: 316860, LOT: 244490, LOT: 141660, REF: (B)(4), REF: (B)(4)." REFERENCE REPORTS: MW5146597, MW5146598.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272462 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI BIOMET, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other