BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK VEPE LINER

    MDR report key: 21918043 · Received April 28, 2025

    Report

    Report Number
    0001822565-2025-01171
    Event Type
    Injury
    Date Received
    April 28, 2025
    Report Date
    April 25, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: SOUTH KOREA . ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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. KIM, J. S., DO, M. U., HAN, J. B., LEE, S.-M., MOON, N. H., SUH, K. T., & SHIN, W. C. (2025). SIMILAR WEAR RATES OF 1ST AND 2ND GENERATION HIGHLY CROSS-LINKED POLYETHYLENE IN PRIMARY TOTAL HIP ARTHROPLASTY IN PATIENTS LESS THAN 30 YEARS OF AGE: A MINIMUM 5-YEAR FOLLOW-UP. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 104178. HTTPS://DOI.ORG/10.1016/J.OTSR.2025.104178

    Description of Event or Problem · 0

    IT WAS REPORTED IN BY A JOURNAL ARTICLE THAT THE PATIENT EXPERIENCED A LINER FRACTURE, RESULTING IN INSTABILITY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A FALL AND PAIN. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 18 MONTHS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237427 UNK VEPE LINER PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention| H