BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC BIPOLAR SHELL

    MDR report key: 9900888 · Received March 30, 2020

    Report

    Report Number
    0001825034-2020-01377
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    February 22, 2020
    Report Date
    June 24, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NI
    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. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED RIGHT TOTAL HIP ARTHROPLASTY WITH SUPER DISLOCATION OF THE FEMORAL HEAD AND ACETABULAR CUP. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE HEAD HAS COME AWAY FROM THE LINER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT WAS 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 00877502802 / BIOLOXÂ HEAD / LOT # 3002512, ITEM # UNKNOWN /UNKNOWN STEM/ LOT # UNKNOWN , ITEM # UNKNOWN/ UNKNOWN LINER/LOT # UNKNOWN. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO DISLOCATION. 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
    361233 E1 RINGLOC BIPOLAR SHELL PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. NI 734200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R