BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC BI-POLAR 28X51MM

    MDR report key: 18703353 · Received February 14, 2024

    Report

    Report Number
    0001825034-2024-00390
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 26, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K051569
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE RINGLOC BI-POLAR 28X51MM ITEM# 11-165226 LOT# 65991003 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE HEAD AND LINER HAVE BEEN ASSEMBLED AND COULD NOT BE REMOVED FROM THE SHELL. THE ASSEMBLY IS SITTING AT AN ANGLE INSIDE OF THE SHELL AND COULD NOT BE REMOVED. NO MEASUREMENTS WERE TAKEN DUE TO THE DEVICE BEING ASSEMBLED AND NOT BEING ABLE TO BE SEPARATED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT WAS CONFIRMED BASED ON THE RETURNED DEVICES, AS THE ASSEMBLY WAS SITTING AT AN ANGLE AND COULD NOT BE REMOVED. 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 · 0

    (B)(4). D10: CAT# 00877502803 LOT# 3180964 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 28/+3.5, TAPER 12/14. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE METAL CUP COULD NOT BE PLACED CORRECTLY OVER THE LINER. AFTER THE LINER WAS PLACED ON THE HEAD AND SNAPPED INTO PLACE, THE CUP WAS PUT ONTO THE LINER AND BECAME STUCK AT AN ANGLE. FORCE WAS USED AND THE PIECES WOULD NOT GO TOGETHER. A SECOND SET OF IMPLANTS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284245 RINGLOC BI-POLAR 28X51MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 65991003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H10 NARRATIVE