BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC HIP SYSTEM

    MDR report key: 6417692 · Received March 20, 2017

    Report

    Report Number
    0001825034-2017-01700
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 17, 2017
    Report Date
    November 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. BASED ON THE CONDITION OF THE RETURNED PRODUCTS, THE COMPLAINT IS CONFIRMED AS THE RING WAS BENT AND THE LINER HAD SOME SCRATCHES AS IF THE LINER HAD BEEN ATTEMPTED TO IMPLANTED AND REMOVED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. 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)(4). AGE- NI. WEIGHT - NI. (B)(4). PMA 510(K): THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510K NUMBER K051569. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE LINER WOULD NOT ASSEMBLED WITH METAL SHELL. THERE WAS NO DELAY OR PATIENT INJURY REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200731 RINGLOC HIP SYSTEM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 265950

    Patients

    Seq Age Sex Outcome Treatment
    1