BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 12X144MM

    MDR report key: 11733523 · Received April 27, 2021

    Report

    Report Number
    0001825034-2021-01172
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    April 5, 2021
    Report Date
    August 23, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304489752
    PMA / PMN Number
    K200196
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. 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 010000662 ITEM NAME G7 PPS LTD ACET SHELL 50D LOT # 6933976, ITEM NUMBER 650-0661 ITEM NAME DELTA CERAMIC FEM HD36/0MM LOT # 3050939, ITEM NUMBER 30123604 ITEM NAME G7 VIT E HIGH WALL LNR 36MMD LOT # 64822914. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS REMAINS IMPLANTED; 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 DEFINITIVE STEM IMPLANT DOES NOT MATCH THE BROACH/TRIAL. THE SURGEON HAS TO REMOVE THE IMPLANT AND RE-BROACH THEN RE-IMPLANTED THE SAME STEM. UPSET THAT IT TAKES EXTRA TIME AND POSSIBLY REMOVES POROUS COATING. 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
    628183 TPRLC 133 T1 PPS HO 12X144MM PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 6954013 00880304489752

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE