BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP T1 PPS SO 8X101MM

    MDR report key: 9706665 · Received February 13, 2020

    Report

    Report Number
    0001825034-2020-00556
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    December 17, 2019
    Report Date
    May 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING THE INTRAOPERATIVE FEMUR FRACTURE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS UNABLE TO 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 PPS LTD ACET SHELL 50D, PN 010000662, LN 6522325, G7 NEUTRAL E1 LINER 36MM D, PN 010000856, LN 6540407, CER BIOLOXD MOD HD 36MM +3 NK, PN 12-115122, LN 2971353. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A STUDY PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT EXPERIENCED AN INTRAOPERATIVE PROXIMAL FEMUR FRACTURE THAT REQUIRED IMMEDIATE ORIF. THE FRACTURE WAS NOTED RESOLVED ONE MONTH AFTER THE INITIAL SURGERY. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172167 TPRLC 133 MP T1 PPS SO 8X101MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 6282949

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R