BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC ACETABULAR BI-POLAR CUP 28X46MM

    MDR report key: 6882056 · Received September 21, 2017

    Report

    Report Number
    0001825034-2017-07232
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Report Date
    March 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEAD WAS RETURNED FOR REVIEW AND THE EVENT WAS CONFIRMED. VISUAL INSPECTION WAS CONDUCTED AND IT WAS IDENTIFIED SOME SCRATCHES AND NICKS ON THE EXTERIOR SURFACE OF THE HEAD. IT WAS VERIFIED THAT THE FEMORAL HEAD WAS STIFF AND WOULD NOT MOVE FREELY INSIDE THE CUP; APPLYING A HIGH FORCE ON THE RIM AREA OF THE HEAD, THE HEAD MOVED SLIGHTLY, BUT NOT AS INTENDED AND THUS THE COMPLAINT IS VERIFIABLE. AS THE CERAMIC HEAD WAS STIFF AND NOT ABLE TO BE REMOVED, A DIMENSIONAL ANALYSIS WAS NOT ABLE TO BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. 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). 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. (B)(4). CONCOMITANT MEDICAL PRODUCTS - 00877502802, BIOLOX® DELTA CERAMIC FEMORAL HEAD, 2895202. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(4). 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 THE HEAD WOULD NOT ARTICULATE WITH THE LINER. THE MOVEMENT OF THE HEAD WAS STIFF. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663094 RINGLOC ACETABULAR BI-POLAR CUP 28X46MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 172970

    Patients

    Seq Age Sex Outcome Treatment
    1