BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS SO 12X144MM

    MDR report key: 21917615 · Received April 28, 2025

    Report

    Report Number
    0001825034-2025-01217
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    October 31, 2024
    Report Date
    October 16, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K200196
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 30103606, G7 VIT E NEUTRAL LNR 36MM F 65454459. 650-0661, DELTA CERAMIC FEM HD 36/0MM 3115228. 010000665, G7 PPS LTD ACET SHELL 56F 7248896. G2: FOREIGN: NETHERLANDS. SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H3, H4, 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. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: MILD PAIN AND LIMB-LENGTH EQUAL.; 1 YEAR; MODERATE PAIN AND PROBLEMS WALKING ABOUT; CANE USE ALL THE TIME, MODERATE LIMP, LEFT LEG SHORT 1CM. SLIGHT PAIN, MODERATE PROBLEMS WALKING ABOUT, CANE USE ONLY FOR LONG WALKS, MODERATE LIMP. LEFT LEG SHORT 0.5CM. PAIN IN RIGHT HIP. LEG LENGTH DIFFERENCE 13MM. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: D4, G3, G6, H2, H4.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AFTER THE FIRST YEAR, DEVELOPED CONTRALATERAL LEG SHORTENING AND BEGAN EXPERIENCING PAIN, A LIMP, AND PROBLEMS WALKING. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY, AND THE OUTCOME IS PENDING.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463893 TPRLC 133 T1 PPS SO 12X144MM PROSTHESIS, HIPS LZO ZIMMER BIOMET, INC. N/A 7162006

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other SEE H11 NARRATIVE.