BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM I.D. SIZE LL ELEVATED RIM LINER

    MDR report key: 15726158 · Received November 4, 2022

    Report

    Report Number
    0001822565-2022-03118
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 11, 2022
    Report Date
    February 6, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K200823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: BRAZIL. CONCOMITANT MEDICAL PRODUCTS: CAT #: 00875305801/ 58MM O.D. SIZE LL POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH LL LINERS/ LOT #: 65417801; CAT #: 00771101100/ FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 11 STANDARD OFFSET/ LOT #: 65309302; CAT #: 00877503203/ BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 32/+3.5, TAPER 12/14/LOT #: 2990975. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4; B5; G3; H2; H3; H6 NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 0

    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 THAT WHILE THE PATIENT WAS BEING TRANSFERRED FROM THE OPERATING TABLE TO THE STRETCHER, THE PROSTHESIS DEFLATED, AND A REVISION PROCEDURE WAS REQUIRED. THE LINER, SHELL, STEM AND HEAD COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING TRANSFERRED FROM THE OPERATING TABLE TO THE STRETCHER, THE PROSTHESIS DISLOCATED, AND A REVISION PROCEDURE WAS REQUIRED. THE LINER, SHELL, STEM AND HEAD COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    THE FEMORAL HEAD COMPONENT WAS REMOVED AND REPLACED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784032 32MM I.D. SIZE LL ELEVATED RIM LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 64551867

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention| H SEE H10.