BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED LINER WITH CONSTRAINING RING USE WITH TRILOGY

    MDR report key: 14238911 · Received April 28, 2022

    Report

    Report Number
    0001822565-2022-01225
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    April 2, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    UDI-DI
    00889024126084
    PMA / PMN Number
    K071718
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00633405028-CONSTRAINED LINER WITH CONSTRAINING RING USE WITH TRILOGY AND TRABECULAR METAL MODULAR ACETABULAR SYSTEMS 28 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHE-64749104 UNKNOWN-UNKNOWN HEAD-UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-01226. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS OF LINER IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO DISLOCATION. DURING THE PROCEDURE THE SURGEON REPLACED THE LINER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98538 CONSTRAINED LINER WITH CONSTRAINING RING USE WITH TRILOGY PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 64749104 00889024126084

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE.