BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X46MM

    MDR report key: 13508963 · Received February 10, 2022

    Report

    Report Number
    0001825034-2022-00318
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    January 19, 2022
    Report Date
    April 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    UDI-DI
    00880304485068
    PMA / PMN Number
    K161190
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT WAS REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM# US157852/ M2A-MAGNUM PF CUP / LOT # 790270, ITEM # 650-1055 / CER BIOLOXD OPTION H/LOT # 2950522, ITEM # 650-1068/ CER OPTION TYPE 1 TPR SLEV/LOT # 2955132. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2022 -00319

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION SURGERY AFTER EXPERIENCING RECURRENT DISLOCATION OF HER THA. THE PATIENT CURRENTLY HAD AN ACTIVE ARTICULATION CONSTRUCT THAT WAS THE RESULT OF A CONVERSION OF A METAL ON METAL MAGNUM CONSTRUCT TO ACTIVE ARTICULATION. 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
    1798740 ACT ARTIC E1 HIP BRG 28X46MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. NI 886660 00880304485068

    Patients

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