BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 RINGLOC BIPOLAR 28X51MM

    MDR report key: 10734270 · Received October 26, 2020

    Report

    Report Number
    0001825034-2020-03892
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 8, 2020
    Report Date
    November 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304568785
    PMA / PMN Number
    NOT CLEARED
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS RETURNED AND EVALUATED AGAINST THE REPORTED EVENT. VISUAL INSPECTION OF THE RETURNED PRODUCT AND PROVIDED PHOTOS FOUND THE INNER STERILE BLISTER WAS CRACKED. THE OUTER STERILE BLISTER WAS INTACT, THEREFORE, STERILITY HAS NOT BEEN BREACHED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE CAN BE ATTRIBUTED TO TRANSIT DAMAGE. THE PRODUCT WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET AND IS THEREFORE CONSIDERED NOT REPORTABLE. 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME. .

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE US, HOWEVER IT IS SIMILAR TO 510K K051569. PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND TO BE DAMAGED WHEN THE PRODUCT WAS OPENED. IT IS UNKNOWN IF THE STERILITY OF THE PRODUCT HAS BEEN COMPROMISED AND THE PRODUCT WAS REMOVED FROM THE FIELD AND A NEW PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DIRECT CONTACT WITH THE PATIENT. 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
    1202739 E1 RINGLOC BIPOLAR 28X51MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 511100 00880304568785

    Patients

    Seq Age Sex Outcome Treatment
    1