BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER STANDARD NECK TYPE 1 TAPER

    MDR report key: 6077406 · Received November 3, 2016

    Report

    Report Number
    0001825034-2016-04349
    Event Type
    Injury
    Date Received
    November 3, 2016
    Report Date
    August 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN.¿

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS - PART: 12-150310 NAME: ECHO PF 10MM STD FEMORAL LOT: 012950 PART: 11-165222 NAME: RINGLOC BI-POLAR 28X49MM LOT:111540. THIS FOLLOW UP REPORT WAS FILED TO REPORT ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS EXPERIENCED PAIN FOLLOWING A HIP PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726147 MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER STANDARD NECK TYPE 1 TAPER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 494570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention