BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM MODULAR HEAD STANDARD NECK TYPE 1 TAPER

    MDR report key: 5998218 · Received October 4, 2016

    Report

    Report Number
    0001825034-2016-03961
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4).

    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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: BIOMET FEMORAL STEM CATALOG #: 192409 LOT #: 832420; BIOMET RINGLOC LINER CATALOG#: 11-165216 LOT#: 444540.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 13 MONTHS POST-IMPLANTATION DUE TO PAIN. DURING THE PROCEDURE, THE HEAD, CUP AND LINER WERE REMOVED AND REPLACED. A COMPETITOR CUP AND LINER WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649117 28MM MODULAR HEAD STANDARD NECK TYPE 1 TAPER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 246960

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R