BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP TYPE1 PPS SO 8.0

    MDR report key: 16193733 · Received January 18, 2023

    Report

    Report Number
    0001825034-2023-00087
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 25, 2022
    Report Date
    January 18, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304489660
    PMA / PMN Number
    K200196
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#: 12-115111 LOT#: 2886400 CER BIOLOXD MOD HD 28MM +3 NK, CAT#: 010000836 LOT#: 3882116 G7 NEUTRAL E1 LINER 28MM B, CAT#: 00625006535 LOT#: 63756283 BONE SCR 6.5X35 SELF-TAP, CAT#: 00625006525 LOT#: 63793449 BONE SCR 6.5X25 SELF-TAP, CAT#: 010000660 LOT#: 3831243 G7 PPS LTD ACET SHELL 46B. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT HAS BEEN DISCARDED. 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: COMPONENT CODE: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FRACTURE LINE EXTENDING TO THE TIP OF THE FEMUR STEM. LARGE POSTEROMEDIAL FRAGMENT AND A GREATER TROCHANTERIC FRAGMENT AND THE SHAFT AS WELL AS FEMUR FRACTURE WERE NOTED. ACETABULAR COMPONENT WAS FOUND TO BE COMPETENT THEREFORE NOT REVISED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, IT IS NOTED THE PATIENT SUSTAINED A FALL PRIOR TO THE FRACTURE. 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 THAT THE PATIENT INITIALLY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT UNDERWENT REVISION APPROXIMATELY FIVE (5) YEARS LATER DUE TO PERIPROSTHETIC FRACTURE AFTER A FALL. THE FRACTURE WAS SECURED WITH A PLATE AND CABLES, AND THE FEMORAL HEAD, STEM, AND ACETABULAR LINER WERE REPLACED WITHOUT COMPLICATION. 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
    977137 TPRLC 133 FP TYPE1 PPS SO 8.0 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 6001667 00880304489660

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H