BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC133 MP T1 PPS SO 6X97.5MM

    MDR report key: 9385203 · Received November 27, 2019

    Report

    Report Number
    0001825034-2019-05376
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 11, 2019
    Report Date
    April 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K110400
    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. EVALUATION OF THE RETURNED PHOTOGRAPHS PROVIDED CONFIRMED DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING AND POROUS COATING FROM THE IMPLANT INSIDE THE STERILE BARRIER THEREFORE, THE REPORTED EVENT IS CONFIRMED AND STERILITY OF THE PRODUCT IS INTACT. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE LIKELY CONDITION OF THE PRODUCT WHEN IT LEFT ZIMMER BIOMET WAS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE. THE EVENT IS BEING ADDRESSED THROUGH THE CAPA PROCESS. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 MP TYPE1 PPS HO 10.0 M T1 CAT# 51-107100 LOT# 3880934, TPRLC 133 MP TYPE1 PPS HO 12.0 M T1 CAT# 51-107120 LOT# 6127326, TLOC 133 MP SP T1 PPS HO 8X101 CAT# 51-109080 LOT# 6086119, TPRLC 133 MP TYPE1 PPS SO 17.0 1 CAT# 51-106170 LOT# 6095775, TPRLC 133 T1 PPS HO 17X154MM 4MM T1 CAT# 51-104170 LOT# 6052090. 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: 0001825034-2019-05375, 0001825034-2019-05377, 0001825034-2019-05378, 0001825034-2019-05379, 0001825034-2019-05380.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS IDENTIFIED WITHIN STERILE PACKAGING. 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
    1181197 TPRLC133 MP T1 PPS SO 6X97.5MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 3925802

    Patients

    Seq Age Sex Outcome Treatment
    1