BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR ACETABULAR COMPONENT

    MDR report key: 6151083 · Received December 7, 2016

    Report

    Report Number
    0001825034-2016-05082
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    March 19, 2015
    Report Date
    May 6, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 2 STATES "DELAYED WOUND HEALING AND/OR EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION. INFECTION CAN LEAD TO FAILURE OF THE JOINT REPLACEMENT." THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-05079 / 05080 /05081 / 05082 / 05083).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K051569.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THIS WILL BE REPORTED UNDER A UK MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION. SUBSEQUENTLY PATIENT EXPERIENCED SUPERFICIAL INFECTION AS WELL AS A URINARY TRACT INFECTION ON 8 DAYS POST-IMPLEMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802903 RINGLOC BI-POLAR ACETABULAR COMPONENT PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3444987

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention