BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC HIP SYSTEM ACETABULAR BIPOLAR CUP

    MDR report key: 6229489 · Received January 6, 2017

    Report

    Report Number
    0001825034-2016-05401
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    December 9, 2016
    Report Date
    December 12, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(4). THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, THIS REPORT IS BEING FILED AS THIS DEVICE IS SIMILAR TO A DEVICE CLEARED UNDER 510K NUMBER K051569. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2016-05400 AND 05401).

    Additional Manufacturer Narrative · 1

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2016 - 05400 - 1.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED. VISUAL INSPECTION OF THE PARTS FOUND NO DAMAGE THAT WOULD PREVENT THE HEAD FROM FREELY ARTICULATING. THE PARTS WERE ASSEMBLED AND THE HEAD ARTICULATED APPROPRIATELY. THE COMPLIANT THEREFORE CANNOT BE CONFIRMED AS THE RETURNED PRODUCTS FUNCTIONED AS INTENDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE FEMORAL HEAD DID NOT MOVE SMOOTHLY WITHIN THE ACETABULAR LINER. ANOTHER HEAD AND LINER WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12508 RINGLOC HIP SYSTEM ACETABULAR BIPOLAR CUP HIP PROSTHESIS JDI BIOMET ORTHOPEDICS N/A 944090

    Patients

    Seq Age Sex Outcome Treatment
    1