BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 FP TYPE1 PPS

    MDR report key: 11280657 · Received February 4, 2021

    Report

    Report Number
    0001825034-2021-00363
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    January 18, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K120030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.THE FOLLOWING SECTIONS WERE UPDATED/CORRECTEDUPDATED: D4; D9; G3; H2; H3; H4; H6VISUAL EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED CONFIRMED THERE IS WHITE DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. THE REPORTED EVENT IS CONFIRMED.DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE FOAM PACKAGING AND POROUS COATING TO BECOME ABRADED AND SHED.UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IN THE STERILE PACKAGING MEETS THE ACCEPTABLE CRITERIA AND PRODUCT IS CONFORMING TO SPECIFICATIONS. FURTHER, THERE WAS NO ADVERSE EVENT AS A RESULT OF THE REPORTED EVENT. THEREFORE, EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED.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). 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 # 51-145170/ TPRLC XR MP T1 PPS/ LOT # 6411825, ITEM# 51-105170/ TPRLC XR T1 PPS/ LOT # 3011823, ITEM # 51-105160/ TPRLC XR T1 PPS /LOT # 6133648, ITEM# 51-107140/ TPRLC 133 MP TYPE1 PPS/ LOT# 6359748, ITEM# 51-107170/ TPRLC 133 MP TYPE1 PPS/ LOT# 3743544, ITEM# 51-145140/ TPRLC XR MP T1 PPS / LOT# 6314883. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034-2021-00357, 0001825034-2021-00358, 0001825034-2021-00359, 0001825034-2021-00360, 0001825034-2021-00361, 0001825034-2021-00362.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHILE REVIEWING PRODUCT AT THE DISTRIBUTORSHIP, IT WAS NOTED THE PRODUCT WAS FOUND TO HAVE DEBRIS INSIDE THE STERILE PACKAGING. 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
    179167 TPRLC 133 FP TYPE1 PPS PROSTHESIS HIP JDI ZIMMER BIOMET, INC. NI 6051655

    Patients

    Seq Age Sex Outcome Treatment
    1