BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HXPE LINER ELEVATED II 32

    MDR report key: 19358925 · Received May 21, 2024

    Report

    Report Number
    0001822565-2024-01666
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    December 28, 2022
    Report Date
    August 28, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024149717
    PMA / PMN Number
    K200823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00877503201 ITEM NAME BIOLOX DELTA, CERAMIC FEMORAL HEAD LOT NUMBER 3111127 65875305201 ITEM NAME 52MM O.D. SIZE II POROUS UNCEMENTED WITH CLUSTER HOLES SHELL LOT # 65378326. G2: FOREIGN: UNITED KINGDOM. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS UNKNOWN WHAT WAS MALALIGNED AND IF THE DEVICES WERE ORIGINALLY PLACED THAT WAY AS FINAL IMPLANT PLACEMENT IS SURGEON DISCRETION. 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 A REVISION PROCEDURE 7 MONTHS AND 7 DAYS POST IMPLANTATION DUE TO MALALIGNMENT, SOCKET DISLOCATION AND SUBLUXATION. THE CUP, HEAD AND LINER WERE ALL REVISED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179340 HXPE LINER ELEVATED II 32 PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 65310641 00889024149717
    501437 HXPE LINER ELEVATED II 32 PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 65310641 00889024149717

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H