BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 44-36 STD HMRL BRNG

    MDR report key: 7467737 · Received April 27, 2018

    Report

    Report Number
    0001825034-2018-02893
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    March 21, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK113121
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EP-115393, E1 44-36 STD HMRL BRNG, 963040, 106021, REGENEREX RINGLOC+ REPLACEMENT RING SZ21, 039870. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02892, 0001825034 - 2018 - 02891.

    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. VISUAL INSPECTION OF THE BEARINGS SHOWED THAT THEY WERE DAMAGED AT THE LIP POSSIBLY DUE TO NOT ALIGNING THE BEARING AND TRAY. NO DIMENSIONAL ANALYSIS WAS PERFORMED ON THE BEARING DUE TO DAMAGE ON THE LIP. THE ARTICULATION SURFACE OF THE BEARINGS DID NOT SHOW ANY DAMAGE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST HUMERAL BEARING WAS DAMAGED DURING A BACK TABLE ASSEMBLY INTO THE HUMERAL TRAY. A NEW RING WAS PUT INTO THE HUMERAL TRAY. THE SECOND HUMERAL BEARING WAS ALSO DAMAGED DURING BACK TABLE ASSEMBLY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312898 E1 44-36 STD HMRL BRNG PROTHESIS, HIP PAO ZIMMER BIOMET, INC. N/A 654320

    Patients

    Seq Age Sex Outcome Treatment
    1