BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC ACETABULAR LINER 36MM SIZE 23 +3MAXROM

    MDR report key: 6016911 · Received October 11, 2016

    Report

    Report Number
    0001825034-2016-04065
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS NUMBER 9 STATES "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, AND/OR EXCESSIVE WEIGHT." NUMBER 14 STATES "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO REPORT CORRECTED INFORMATION. THE INITIAL MDR SHOULD HAVE REFLECTED SEP 13, 2016 AS THIS WAS THE INITIAL DATE RECEIVED BY MANUFACTURER. CONCOMITANT MEDICAL PRODUCTS: 16-104152, LOT 360450, RINGLOC+ SHELL; 650-1057, LOT 315010, CERAMIC BIOLOX HEAD; 650-1065, LOT 131280, CERAMIC TYPE 1 TAPER; 51-103090, LOT 2961629, TAPERLOC TYPE 1 PPS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO A LINER FRACTURE AND RESULTANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669265 E1 RINGLOC ACETABULAR LINER 36MM SIZE 23 +3MAXROM PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 996310

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R