BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP E1 ANTIOXIDANT INFUSED 28MM X 44MM

    MDR report key: 6148735 · Received December 6, 2016

    Report

    Report Number
    0001825034-2016-05058
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 7, 2016
    Report Date
    February 10, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    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 PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051569. THEREFORE, THIS IS REPORTABLE. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-05058 / 05059).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 163663, 28MM MOD HD COCR +3MM, 556950. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE PRODUCTS WERE RETURNED AND EVALUATED AGAINST THE COMPLAINT. NO DAMAGE OR DEFORMITIES WERE OBSERVED ON EITHER DEVICE. THE OUTER SURFACE PROFILE OF EACH DEVICE IS ALSO FREE OF DAMAGE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPERATION THE SURGEON ENCOUNTERED ARTICULATION BETWEEN THE HEAD AND LINER THAT WAS "HARD." THE PROCEDURE WAS COMPLETED WITH ANOTHER BIPOLAR PRODUCT WITH A 50 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799609 RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP E1 ANTIOXIDANT INFUSED 28MM X 44MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 397210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O