BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC 133 MP TYPE1 PPS HO 16.0 M T1

    MDR report key: 9574265 · Received January 10, 2020

    Report

    Report Number
    0001825034-2020-00163
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 23, 2019
    Report Date
    March 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO BREACH IN STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO BREACH IN STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC XR T1 PPS 15X150MM MM T1: CAT#51-105150, LOT#: 6181085. REPORT SOURCE: FOREIGN COUNTRY (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00162.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE INVESTIGATING CIRCULATED ITEMS, STERILE PACKAGES WERE FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. 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
    40165 TAPERLOC 133 MP TYPE1 PPS HO 16.0 M T1 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. NI 6228143

    Patients

    Seq Age Sex Outcome Treatment
    1