BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERAMIC LINER

    MDR report key: 13592534 · Received February 24, 2022

    Report

    Report Number
    0001822565-2022-00598
    Event Type
    Injury
    Date Received
    February 24, 2022
    Report Date
    March 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    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). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED; 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. A DEFINITIVE ROOT CAUSE COULD NOT 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 IN A JOURNAL ARTICLE THAT ONE (1) PATIENT UNDERWENT LINER REVISION DUE TO CERAMIC LINER FRACTURE AT THE END OF THE FOURTH YEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079912 UNKNOWN CERAMIC LINER PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R UNKNOWN HEAD| UNKNOWN SHELL| UNKNOWN STEM