BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 18X156MM

    MDR report key: 11819389 · Received May 13, 2021

    Report

    Report Number
    0001825034-2021-01464
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 27, 2021
    Report Date
    September 2, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304499263
    PMA / PMN Number
    K200196
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.   NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A 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. 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER 650-0662 ITEM NAME DELTA CERAMIC FEM HD36/+3MM LOT # 3033496. ITEM NUMBER 010000668 ITEM NAME G7 PPS LTD ACET SHELL 62H LOT # 6629901. ITEM NUMBER 30103608 ITEM NAME G7 VIT E NEUTRAL LNR 36MM H LOT # 64460748. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS LOCATION UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE AND WAS REVISED TWO (2) WEEKS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712831 TPRLC 133 T1 PPS HO 18X156MM PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 6081367 00880304499263

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE