BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 19831327 · Received July 25, 2024

    Report

    Report Number
    0001822565-2024-02461
    Event Type
    Injury
    Date Received
    July 25, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNKNOWN HEAD UNKNOWN; UNKNOWN LINER UNKNOWN; UNKNOWN STEM UNKNOWN. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT TOTAL HIP ARTHROPLASTY WITH POLYETHYLENE WEAR OF THE ACETABULAR CUP AS WELL AS BONY IMPACTION OF HETEROTOPIC OSSIFICATION ALONG THE LATERAL ACETABULUM AND THE GREATER TROCHANTER, LIKELY LIMITING MOBILITY. NO PROBLEM WAS FOUND WITH THE DEVICES RELATED TO THE HO, AS REVIEW BY A HCP DETERMINED THAT WAS NOT DEVICE RELATED. THIS COMPLAINT CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254913 UNKNOWN CUP PROSTHESIS, HIPS JDI ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.