BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ARTICULATION HIP SYSTEM E1 HIP BRG 28X44MM

    MDR report key: 19773069 · Received July 18, 2024

    Report

    Report Number
    0001825034-2024-01870
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 27, 2024
    Report Date
    November 14, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485051
    PMA / PMN Number
    K161190
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, G3, G6, H2, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: LEFT TOTAL HIP ARTHROPLASTY WITH ASSOCIATED SUPERIOR AND POSTERIOR DISLOCATION OF THE FEMORAL HEAD AND EVENTUAL WITHDRAWAL OF THE FEMORAL COMPONENT WITH ASSOCIATED COMPONENT ROTATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVENT IS CONFIRMED VIA MEDICAL RECORDS. 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). D10: 00-8114-001-10 ITEM NAME CPT 12/14 SIZE 1 COCR EXT LOT # 66481402 802202802 FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +0 MM NECK LENGTH 3190326 110024464, ITEM NAME G7 DUAL MOBILITY LINER 44MM F, LOT # 66310981, G2: FOREIGN: AUSTRALIA. 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

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 2 MONTHS AND 13 DAYS POST IMPLANTATION DUE TO DISLOCATION. THE STAFF IN EMERGENCY DEPARTMENT ATTEMPTED CLOSED REDUCTION UNSUCCESSFULLY. THIS RESULTED IN BOTH THE HEAD DISSOCIATING FROM THE DM BEARING AND THE CPT STEM MIGRATING CRANIALLY OUT OF THE CEMENT MANTLE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555517 ACTIVE ARTICULATION HIP SYSTEM E1 HIP BRG 28X44MM PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 66246658 00880304485051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R PLEASE SEE H11.