BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLOC 133 MP SP T1 PPS HO 8X101

    MDR report key: 24199032 · Received January 28, 2026

    Report

    Report Number
    0001825034-2026-00238
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    April 7, 2024
    Report Date
    January 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K200823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. D10: CAT# 650-1057 LOT# 2904517 CER BIOLOXD OPTION HD 36MM. CAT# 650-1064 LOT# 2900787 CER OPTION TYPE 1 TPR SLEVE -6. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: D4; G3; H2; H3; H4; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) 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: 5 YEARS FOLLOW UP VISIT PARTICIPATES IN MILD ACTIVITIES REGULARLY, SOME MILD DIFFICULTY WITH ADLS AE ENTERED PATIENT REPORTED ANTERIOR LEFT HIP PAIN, 8/10 INTENSITY. PAIN MEDICATION PRESCRIBED- TRAMADOL. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED LEFT ANTERIOR HIP PAIN APPROXIMATELY 5 YEARS AND 10 MONTHS POST-IMPLANTATION. IMAGING DID NOT DEMONSTRATE ANY PROSTHETIC ISSUES, AND MEDICATION WAS PRESCRIBED. NO FALL OR TRAUMA WERE REPORTED. THE PATIENT REMAINED IN THE STUDY WITH ALL INITIAL COMPONENTS RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260234 TLOC 133 MP SP T1 PPS HO 8X101 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. 3590303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11 NARRATIVE.