BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 10.0

    MDR report key: 7556428 · Received May 31, 2018

    Report

    Report Number
    0001825034-2018-03595
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 2, 2018
    Report Date
    December 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK110400
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: DATE OF REPORT, EVENT, PMA/ 510K, TYPE OF REPORTABLE EVENT, FOLLOW-UP, DEVICE EVALUATED BY MFR, CODES. UDI: (B)(4). REPORTED EVENT IS CONSIDERED CONFIRMED AS VISUAL EXAMINATION SHOWED THE PACKAGING HAD DEBRIS INSIDE. THE STERILE BARRIER WAS STILL INTACT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE LIKELY CONDITION OF THE PRODUCTS WHEN LEAVING ZIMMER BIOMET WAS NON-CONFORMING. THE REPORTED EVENT OCCURRED DURING THE MANUFACTURING PROCESS. THEREFORE THE ROOT CAUSE WAS MANUFACTURING DEFICIENCY. 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). CONCOMITANT PRODUCTS: 51-106100, TPRLC 133 MP TYPE1 PPS SO 10.0, 6232162; 51-106130, TPRLC 133 MP TYPE1 PPS SO 13.0, 6238486. (B)(6). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. 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 - 2018 - 03594, 0001825034 - 2018 - 03596.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCOMING INSPECTION MEMBER FOUND DEBRIS IN THE STERILE PACKAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401564 TPRLC 133 MP TYPE1 PPS SO 10.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6232162

    Patients

    Seq Age Sex Outcome Treatment
    1