BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 FP TYPE1 PPS HO

    MDR report key: 11345919 · Received February 18, 2021

    Report

    Report Number
    0001825034-2021-00515
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 27, 2021
    Report Date
    February 18, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    UDI-DI
    00880304499072
    PMA / PMN Number
    K103755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED CONCOMITANT MEDICAL PRODUCTS: ITEM # 51-102050/ TPRLC XR FP TYPE1 PPS/ LOT # 6219048, ITEM# 51-105140/ TPRLC XR T1 PPS / LOT # 6222400. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034 -2021 -00513, 0001825034 -2021 -00514.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING INVESTIGATION OF PRODUCT AT THE DISTRIBUTORSHIP, THE PACKAGING WAS 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
    239541 TPRLC 133 FP TYPE1 PPS HO PROSTHESIS HIP KWL ZIMMER BIOMET, INC. NI 6114646 00880304499072

    Patients

    Seq Age Sex Outcome Treatment
    1