BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY RINGLOC LINER

    MDR report key: 6757731 · Received August 1, 2017

    Report

    Report Number
    0001825034-2017-05517
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    May 5, 2017
    Report Date
    February 9, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070399
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT PRODUCTS: 103532 TI LOW PROFILE SCREW 412990; 103531 TI LOW PROFILE SCREW 202700; 14-103652 UNIVERSAL HOLE HELL 372330; 51-101080 TAPERLOC STEM 3804137; 163669 MODULAR HEAD 910780.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY SUBSEQUENTLY THE PATIENT EXCHANGE OF LINER AND HEAD WAS PERFORMED DUE TO INFECTION. THE PATIENT WAS PUT ON 6 WEEKS OF IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538140 EPOLY RINGLOC LINER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 357560

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Congenital Anomaly| H