BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM REDUCED DISTAL

    MDR report key: 8540733 · Received April 23, 2019

    Report

    Report Number
    0001825034-2019-01771
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    March 28, 2019
    Report Date
    June 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K120030
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI # (B)(4). REPORT SOURCE : AUSTRALIA. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 · 0

    CONCOMITANT MEDICAL PRODUCTS: PART: 010000664, G7 PPS LTD ACET SHELL 54F, LOT: 6329654 PART: 110024464, G7 DUAL MOBILITY LINER 44MM F, LOT: 424110 PART: 650-1157, DELTA CER FEM HD, LOT: 201801994 PART: EP-200150, ACT ARTIC E1 HIP BRG 28X44MM, LOT: 820760.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY THEN THE PATIENT FELL IN WARD AND RESULTING IN A PERIPROSTHETIC FRACTURE OF THE FEMUR. SUBSEQUENTLY, TWO DAYS AFTER THE INITIAL SURGERY, THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334473 TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM REDUCED DISTAL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6147977

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R