BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 12X144MM

    MDR report key: 11494782 · Received March 16, 2021

    Report

    Report Number
    0001825034-2021-00772
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 24, 2021
    Report Date
    July 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304489752
    PMA / PMN Number
    K101086
    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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ZIMMER G7 VIT E NEUTRAL LNR 36MM F, CAT#: 30103606, LOT#: 64952318; BIOMET CER BIOLOXD MOD HD 36MM +6 NK, CAT#: 12-115123, LOT#: 2972001; BIOMET G7 PPS LTD ACET SHELL 56F, CAT#: 10000665, LOT#: 6807678. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO HOSPITAL POLICY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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 LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH LATER DUE TO LEG LENGTH DISCREPANCY. THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED. 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
    388103 TPRLC 133 T1 PPS HO 12X144MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6786095 00880304489752

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R