BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7

    MDR report key: 23737364 · Received December 8, 2025

    Report

    Report Number
    0001825034-2025-03880
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    September 21, 2019
    Report Date
    April 22, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527164
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H6; H10. 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. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: 3-YEAR POST-OP PATIENT REPORTS SOMETIMES PARTICIPATING IN ACTIVITIES SUCH AS WALKING. MODERATE PAIN, SLIGHT LIMP, CANE USED MOST OF THE TIME. OFFICE VISIT PAIN 1 OUT OF 10, NO FURTHER PROBLEMS REPORTED. AMBULATES WITH WALKER. 5-YEAR POST-OP PATIENT REPORTS BEING MOSTLY INACTIVE. MODERATE PAIN, SLIGHT LIMP, USES TWO CANES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS CONFIRMED. 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# 650-1058; LOT# 771480; CER BIOLOXD OPTION HD 40MM. CAT# 650-1064; LOT# 843540; CER OPTION TYPE 1 TPR SLEVE -6. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A 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 APPROXIMATELY THREE YEARS POST-HIP SURGERY, THE PATIENT EXPERIENCED MODERATE PAIN AND USING CANES FOR AMBULATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422147 G7 PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 3722429 00880304527164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other