BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X50MM

    MDR report key: 18171299 · Received November 20, 2023

    Report

    Report Number
    0001825034-2023-02663
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    October 28, 2023
    Report Date
    February 29, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485082
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED BIO-DEBRIS TO THE SURFACE OF THE BEARING. NO DAMAGE WAS NOTED TO THE INNER SPHERICAL SURFACE. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEW IDENTIFIED THE FOLLOWING: 1. LIMITED STUDY GIVEN SIGNIFICANT ARTIFACT; 2. POSSIBLE POLYETHYLENE WEAR OF THE ACETABULAR CUP; 3. POSSIBLE LOOSENING OF THE FEMORAL COMPONENT AT THE BONE CEMENT INTERFACE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. THE X-RAY REVIEW COULD NOT CONFIRM THE REPORTED EVENT. 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: CAT# 110024466, LOT# 890570, G7 DUAL MOBILITY LINER 50MM H. CAT# 00-8777-028-03, LOT# 3009348, BIOLX OPT HD/ADPT 12/14 28+3.5. UNK STEM . G2: FOREIGN AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION APPROXIMATELY EIGHT MONTHS POST-IMPLANTATION DUE TO INTRA PROSTHETIC DISLOCATION BETWEEN THE HEAD AND BEARING. THE HEAD, LINER, AND STEM WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046150 ACT ARTIC E1 HIP BRG 28X50MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 798960 00880304485082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE.