BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X40MM

    MDR report key: 19642752 · Received July 1, 2024

    Report

    Report Number
    0001825034-2024-01708
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 31, 2024
    Report Date
    October 23, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485037
    PMA / PMN Number
    K161190
    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: 00877502802 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14 2955166. G2: FOREIGN: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 AND/OR CORRECTED INFORMATION. UPDATED: D4, G3, G6, H2, H3, H6. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE LINER WITH NICKS AND GOUGES ON THE OUTER EDGES AND INNER SURFACE. NO IMAGES OF THE OUTER SURFACE OF THE LINER WERE PROVIDED. NO IMAGES OF THE BEARING WERE PROVIDED. NO PRODUCT WAS RETURNED; DETAILED VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION, UNABLE TO CONFIRM COMPLAINT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION FIVE (5) YEARS POST IMPLANTATION. THE CAUSE FOR THE DISLOCATION IS UNKNOWN. THE STEM, HEAD, AND BEARINGS WERE REPLACED. THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851756 ACT ARTIC E1 HIP BRG 28X40MM PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 870090 00880304485037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.