BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC BIPOLAR HIP SYSTEM

    MDR report key: 22043515 · Received May 19, 2025

    Report

    Report Number
    0001825034-2025-01449
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 11, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00887868418693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: JAPAN. G4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO PREMARKET NOTIFICATION 510(K) CAN BE DETERMINED. THE DEVICE IS CONSIDERED SIMILAR TO PRODUCT#: 11-165208 AND 510(K) # K051569. THE 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6 VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE DEVICES, BUT CANNOT BE USED TO CONFIRM THE REPORTED EVENT. DEVICES NOT RETURNED, FURTHER ANALYSIS CANNOT BE MADE. BEARING AND CUP - REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RINGLOC - REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. LOCKING RING - THE DEVICE HISTORY RECORDS FOR ITEM #11-165210-04, LOT # 67035236 WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH THE FOLLOWING RELATED ANOMALIES/DEVIATIONS IDENTIFIED: NCI00200193 MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. 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 CUP AND LINER COULD NOT BE ASSEMBLED INTRAOPERATIVELY AND THE LOCKING RING WAS BENT. ANOTHER PRODUCT WAS AVAILABLE. THERE WAS A 3-5 MINUTE DELAY. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138654 RINGLOC BIPOLAR HIP SYSTEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. 66973390 00887868418693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown