BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X40MM

    MDR report key: 23607594 · Received November 20, 2025

    Report

    Report Number
    0001825034-2025-03720
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    November 12, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485037
    PMA / PMN Number
    K161190
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-1159 LOT# 3093881 DELTA CER FEM HD 28/-3MM T1. G2: FOREIGN: AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. 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. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: G3; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT TOTAL HIP ARTHROPLASTY. FEMORAL OFFSET IS GREATER AT THE RIGHT HIP ARTHROPLASTY COMPARED WITH THE LEFT NATIVE HIP. INCREASED FEMORAL OFFSET MAY BE A RISK FACTOR FOR SYMPTOMS OF ILIOPSOAS IMPINGEMENT. LACK OF LATERAL VIEW LIMITS ASSESSMENT FOR OTHER RISK FACTORS, SUCH AS ANTERIOR ACETABULAR CUP OVERHANG. 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 THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY A YEAR AND A HALF LATER DUE TO ONGOING PAIN, SPECIFICALLY IN HIP FLEXION AND EXTERNAL ROTATION. THE JOINT WAS OPENED AND THE CUP ORIENTATION EVALUATED. THE SURGEON FELT THAT THE CUP WAS CAPTURED BY BONE (SO WAS NOT PROUD). AN ILIOPSOAS RELEASE WAS PERFORMED AND A NEW BEARING AND HEAD IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293696 ACT ARTIC E1 HIP BRG 28X40MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER BIOMET, INC. 66191003 00880304485037

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Hospitalization| R SEE H11 NARRATIVE.