BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR 28X52MM

    MDR report key: 11393487 · Received March 1, 2021

    Report

    Report Number
    0001825034-2021-00592
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    January 17, 2021
    Report Date
    June 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304001930
    PMA / PMN Number
    K051569
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B5; G3; H2. 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 · 0

    IT WAS REPORTED THAT THE SURGEON CONTRIBUTES THE DISLOCATION TO THE PATIENT THRASHING AND MOVING AROUND IN THE MIDDLE OF THE NIGHT. THEREFORE, THERE WAS NO ALLEGED PRODUCT DEFECT ASSOCIATED WITH THE DISLOCATION AND THE RECORD WILL BE UPDATED TO NOT A COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 163661-28MM DIA COCR MOD HD -3MM NK-760250. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00591. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 3 DAYS¿ POST IMPLANTATION DUE TO DISLOCATION. PATIENT HAD A FIX HIP AND A RINGLOC BIPOLAR CUP WAS PUT IN. PATIENT HAS DEMENTIA AND WHEN SHE WOKE UP AT NIGHT AND DID NOT KNOW WHERE SHE WAS SHE BEGAN THRASHING AND DISASSOCIATED THE 28MM HEAD FROM THE 52 BIPOLAR CUP CONSTRUCT. AFTER ATTEMPTS TO REDUCE AN X-RAY WAS TAKEN AND THE PROBLEM WAS NOTICED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289885 RINGLOC BI-POLAR 28X52MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 692240 00880304001930

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R