BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM CEMENTLESS COLLARED HIGH OFFSET 12/14 TAPER SIZE 3

    MDR report key: 21787198 · Received April 7, 2025

    Report

    Report Number
    0001822565-2025-00919
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    November 21, 2024
    Report Date
    May 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024509153
    PMA / PMN Number
    K182048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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: H6 SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. 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 PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: GREATER TROCHANTER PAIN AND BILATERAL KNEE PAIN. STEROID INJECTION GIVEN AS WELL AS MEDROL DOEPAK. AT FOLLOW-UP: PATIENT REPORTS NO PROBLEMS WITH ADL¿S, NO PAIN. LEG LENGTHS EQUAL, NO LIMP NOTED. RADIOGRAPHS WERE NOT SENT TO MMI AS SENDING THE IMAGES WOULD NOT ENHANCE THE INVESTIGATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED BASED ON THE MEDICAL RECORD FINDINGS. 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: 20103605 ITEM NAME 36MM I.D. SIZE E NEUTRAL LINER LOT # 65255951, 010000663 ITEM NAME G7 PPS LTD ACET SHELL 52E LOT # 7127194, 00877503602 ITEM NAME BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14 LOT # 3090848. H6: COMPONENT CODE: STEM. 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 2 AND A HALF YEARS POST IMPLANTATION, THE PATIENT WAS GIVEN A DEPO-MEDROL INJECTION AS WELL AS PRESCRIBED MEDROL DOEPAK 4MG TABLETS DUE TO GREATER TROCHANTER PAIN AS WELL AS BILATERAL KNEE PAIN. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730944 FEMORAL STEM CEMENTLESS COLLARED HIGH OFFSET 12/14 TAPER SIZE 3 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 3074345 00889024509153

    Patients

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