BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X44MM

    MDR report key: 16243295 · Received January 25, 2023

    Report

    Report Number
    0001825034-2023-00153
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    January 5, 2023
    Report Date
    March 9, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485051
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE CERAMIC HEAD HAS SCUFFING ON THE OUTSIDE RADIUS AND ALSO INSIDE OF THE TAPER. THE RETURNED LINER HAS INDENTATIONS ON THE OUTER RADIUS OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157850 M2A-MAGNUM PF CUP 50ODX44ID LOT NUMBER 249530. 193009 ECHO B-MTRC MP FP SO 9 LOT NUMBER 681140. 12-115110 CER BIOLOXD MOD HD 28MM STD NK LOT NUMBER 2983168. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET. THE INVESTIGATION IS CURRENTLY IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO THE 44MM ACTIVE ARTICULATION PLOY BALL DISASSOCIATING FROM THE 28MM CERAMIC INNER BALL AFTER A CLOSED REDUCTION IN AN ER SETTING. THE SURGEON REVISED TO A 44F DUAL MOBILITY VIVACITE BALL AND A CERAMIC 28MM HEAD WHEN THE PATIENT SHOWED UP IN THE ER. THE SURGEON WHO PERFORMED THE REVISION DID NOT DO THE PRIMARY SURGERY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793577 ACT ARTIC E1 HIP BRG 28X44MM PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 530940 00880304485051

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H PLEASE SEE H10