BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS SO 15X150MM

    MDR report key: 18282011 · Received December 7, 2023

    Report

    Report Number
    0001825034-2023-02845
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    November 6, 2023
    Report Date
    March 14, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304491861
    PMA / PMN Number
    K200196
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. H6: PROPOSED 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. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE 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# 650-1055, LOT# 3144942, CER BIOLOXD OPTION HD 28MM. CAT# 650-1064, LOT# 3130573 , CER OPTION TYPE 1 TPR SLEVE -6. CAT# 110031013, LOT# 65560590, VIVACIT-E DM BEARING 28X46MM. 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.

    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 THE PATIENT UNDERWENT A REVISION THREE DAYS POST-IMPLANTATION DUE TO A PERIPROSTHETIC FRACTURE FROM AN UNKNOWN CAUSE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199932 TPRLC 133 T1 PPS SO 15X150MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A J7449893 00880304491861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R