BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC HIP SYSTEM ACETABULAR LINER

    MDR report key: 7054201 · Received November 22, 2017

    Report

    Report Number
    0001825034-2017-10537
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: BIOLOX DELTA HIP SYSTEM CERAMIC HEAD, CATALOG#: 650-1058, LOT#: 637300 TAPERLOC 133 FP TYPE1, CATALOG#: 51-100130, LOT#: 2811463. CERAMIC OPTION TYPE 1 TAPER SLEVE, CATALOG#: 650-1065, LOT#: 026670. TRI-SPIKE SHELL, CATALOG#: 101007, LOT#: 596230. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE REMAINS 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-10537, 10544.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGED TO RIGHT HIP PAIN AND DISLOCATION TEN MONTHS POST-IMPLANTATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833569 RINGLOC HIP SYSTEM ACETABULAR LINER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 000330

    Patients

    Seq Age Sex Outcome Treatment
    1 Other