BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 16.0

    MDR report key: 13591407 · Received February 24, 2022

    Report

    Report Number
    0001825034-2022-00395
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    February 2, 2022
    Report Date
    April 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304513556
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1065 ¿ BIOLOX TAPER SLEEVE ¿ 3065252, 30124007 ¿ G7 VIT E LINER ¿ 65126866, 00625006540 ¿ BONE SCREW - J7009624, 00625006535 ¿ BONE SCREW - J7105901, 650-1058 ¿ BIOLOX HEAD ¿ 3041413, 010000667 ¿ G7 CUP ¿ 6972025. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; G3; H2; H3; H4; H6 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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

    IT WAS REPORTED THAT DURING A RIGHT HIP PROCEDURE, THE STEM WAS FOUND TO BE SITTING PROUD. THE SURGEON HAD TO USE A BIGGER BROACH TO GET THE STEM TO SIT PROPERLY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330211 TPRLC 133 MP TYPE1 PPS HO 16.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 7022599 00880304513556

    Patients

    Seq Age Sex Outcome Treatment
    1 Male