BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIPOLAR BIPOLAR SHELL 50 MM O.D.

    MDR report key: 19457663 · Received June 4, 2024

    Report

    Report Number
    0002648920-2024-00174
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    May 15, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    UDI-DI
    00889024115422
    PMA / PMN Number
    K872019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. XRAY REVIEWED AND NOT SUBMITTED AT THIS TIME AS IMAGE IS UNDATED AND WOULD BE DIFFICULT TO CORRELATED TO PRESENCE OF EROSION AS ALLEGED A DEFINITIVE 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 · 0

    (B)(4). D10: CAT# 00500105028 LOT# 65562632 LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS. CAT# 00811400310 LOT# 65270823 FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 3 130 MM STEM LENGTH. CAT# 802202802 LOT# 3070638 FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +0 MM NECK LENGTH. G2: FOREIGN: AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER DUE TO ACETABULAR BONE LOSS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659703 MULTIPOLAR BIPOLAR SHELL 50 MM O.D. PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 65532033 00889024115422

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention| H SEE H11 NARRATIVE