BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 12X144MM

    MDR report key: 7764116 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-07103
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    August 29, 2016
    Report Date
    September 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY MEDICAL RECORDS, CT SCAN AND XRAYS RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN CUP; UNKNOWN LINER; 650-1057 CER BIOLOXD OPTION HD 36MM, 5771760; 650-1064 CER OPTION TYPE 1 TPR SLEVE -6, 753310. THE COMPLAINT IS IN INVESTIGATION, ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY RIGHT TOTAL HIP ARTHROPLASTY AND PATIENT OBTAINED AN INTRA-OPERATIVE CALCAR FRACTURE WHICH WAS FIXED USING PROXIMAL CABLES NOW THE PATIENT WAS REVISED ORIF WITHIN ONE MONTH DUE TO SUBSIDENCE OF STEM AND SUBSEQUENT FEMUR FRACTURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604549 TPRLC 133 T1 PPS HO 12X144MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3760692

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R