BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 15X150MM 0MM T1

    MDR report key: 9749682 · Received February 25, 2020

    Report

    Report Number
    0001825034-2020-00858
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    February 7, 2020
    Report Date
    April 14, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQG
    PMA / PMN Number
    K101086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED PRODUCT CONFIRMED THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER AND POROUS PARTICULAR FROM THE IMPLANT. STERILITY OF THE PRODUCT IS INTACT AND REPORTED EVENT IS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 MP TYPE1 PPS HO 16.0 M T1 CAT# 51-107160 LOT# 6156230, TPRLC XR MP T1 PPS 17X119MM 119MM T1 CAT# 51-145170 LOT# 2898306, TPRLC XR MP T1 PPS 15X115MM 115MM T1 CAT# 51-145150 LOT# 3739732, TPRLC XR MP T1 PPS 16X117MM 117MM T1 CAT# 51-145160 LOT# 3791241, TPRLC XR MP T1 PPS 15X115MM 115MM T1 CAT# 51-145150 LOT# 3756093. 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: 0001825034-2020-00856, 0001825034-2020-00857, 0001825034-2020-00859, 0001825034-2020-00860, 0001825034-2020-00861.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS FOUND WITHIN STERILE PACKAGES WHILE INVESTIGATING CIRCULATED ITEMS. NO HOSPITALS WERE INVOLVED. 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
    213781 TPRLC 133 T1 PPS HO 15X150MM 0MM T1 PROSTHESIS, HIP OQG ZIMMER BIOMET, INC. NI 3838102

    Patients

    Seq Age Sex Outcome Treatment
    1