BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HXPE LINER NEUT 58 LL X 36

    MDR report key: 18921555 · Received March 18, 2024

    Report

    Report Number
    0001822565-2024-00847
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 20, 2024
    Report Date
    July 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024149236
    PMA / PMN Number
    K200823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT #: 650-0660 / DELTA CERAMIC FEM HD 36/-3MM / LOT #: 3159543 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: B4; B5; G3; H2; H3; H4; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: RIGHT HIP ARTHROPLASTY DISLOCATION. COMPLAINT WAS CONFIRMED VIA THE EVALUATION OF THE PROVIDED MEDICAL RECORDS. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION ON THE SAME DAY AS THE INITIAL IMPLANT DUE TO A POST-OP DISLOCATION. THE LINER AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192659 HXPE LINER NEUT 58 LL X 36 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. NI 65501354 00889024149236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE