BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X44MM

    MDR report key: 17479989 · Received August 8, 2023

    Report

    Report Number
    0001825034-2023-01836
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    June 29, 2023
    Report Date
    August 7, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 650-1065 CER OPTION TYPE 1 TPR SLEVE - 3 LOT NUMBER IS 3050891; 650-1055 CER BIOLOXD OPTION HD 28MM LOT NUMBER IS 3050659; 010000996 G7 SCREW 6.5MM X 15MM LOT NUMBER IS 6944412; 010000996 G7 SCREW 6.5MM X 15MM LOT NUMBER IS 6944412; 110010265 G7 OSSEOTI MULTIHOLE 54MM F LOT NUMBER IS 6746594; 51-108080 TPRLC 133 MP T1 PPS SO 8X101MM LOT NUMBER IS 6839395. G2: FOREIGN: JAPAN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. UNABLE TO CONFIRM COMPLAINT AS NO PRODUCT WAS RETURNED, IMAGES PROVIDED, OR MEDICAL RECORDS WERE PROVIDED. 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. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS AND 3 MONTHS POST IMPLANTATION DUE TO DISLOCATION OF THE BEARING FROM THE HEAD. IT WAS DISCOVERED THAT THE BEARING WAS REMOVED FROM THE HEAD DURING THE REVISION SURGERY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157790 ACT ARTIC E1 HIP BRG 28X44MM PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 022880 00880304485051

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R PLEASE SEE H10