BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC BIPOLAR 28X53MM

    MDR report key: 11580752 · Received March 29, 2021

    Report

    Report Number
    0001825034-2021-00909
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    February 17, 2021
    Report Date
    August 23, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304588822
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE IS 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 · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 110010468 ¿ RINGLOC BIPOLAR -745380; UNKNOWN STEM - UNKNOWN PART AND LOT. REPORT SOURCE (B)(6). 510K NOT CLEARED, DEVICE IS SAME OR SIMILAR TO K051569. CUSTOMER HAS INDICATED THAT THE 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 00911.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED A DISLOCATION AND WAS MANUALLY REDUCED AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION. DURING THE REDUCTION, THE BIPOLAR CUP CAME OFF THE HEAD. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 5 DAYS LATER. 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
    480437 E1 RINGLOC BIPOLAR 28X53MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 745380 00880304588822

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10