BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 14137688 · Received April 18, 2022

    Report

    Report Number
    0001822565-2022-01117
    Event Type
    Injury
    Date Received
    April 18, 2022
    Report Date
    April 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CAGRI ORS, MD, REMZI CAYLAK, MD, EMRE TOGRUL, MD. (16 JUNE 2021). TOTAL HIP ARTHROPLASTY WITH THE WAGNER CONE FEMORAL STEM IN PATIENTS WITH CROWE IV DEVELOPMENTAL DYSPLASIA OF THE HIP: A RETROSPECTIVE STUDY, 37 (2022) 103-109. HTTPS://DOI.ORG/10.1016/J.ARTH.2021.09.007. FOREIGN REPORT SOURCE: (B)(6). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 ¿ 00597, 0001822565 - 2022 - 01118 , 0001822565 - 2022 - 01119.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THREE (3) PATIENTS UNDERWENT ACETABULAR REVISIONS DUE TO ASEPTIC LOOSENING. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627436 UNKNOWN SCREW PROSTHESIS, HIP HWC ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H UNKNOWN HEAD| UNKNOWN LINER| UNKNOWN STEM