BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM

    MDR report key: 7354587 · Received March 20, 2018

    Report

    Report Number
    3005985723-2018-00181
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 20, 2018
    Report Date
    April 18, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING PRODUCT MIX INVOLVING A MAKO BASEPLATE TRIAL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: THE PRODUCTS WERE RETURNED WITH THE PACKAGING. TWO BASEPLATE TRIALS WERE RETURNED, CATALOG 170604 LOT 26080916. THE TRIALS WERE IN NEW CONDITION. BOTH BASEPLATE TRIALS HAD CATALOG #170604 ON DEVICE WITH PACKAGE LABELS FOR INSERT TRIALS, CATALOG 170706-1 LOT NUMBER 12371116. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. -PRODUCT HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAS BEEN 7 OTHER EVENTS FOR THE LOT INDICATED. CONCLUSIONS: THE INVESTIGATION CONFIRMED THE REPORTED EVENT OF A PRODUCT MIX BETWEEN THE TRIAL BASEPLATE AND TRIAL INSERT. NC WAS ISSUED ON (B)(6) 2017 FOR THE PRODUCT MIX. THE NC DETERMINED THE ROOT CAUSE OF THIS EVENT WAS A LACK OF STANDARD WORK WHERE PERSONNEL DID NOT PERFORM PROPER LINE CLEARANCE DUE TO A LACK OF TRAINING.

    Description of Event or Problem · 0

    AS REPORTED: "PRODUCTS 170706-1 WERE ORDERED AND WHAT IS LISTED ON THE PACKAGING BUT PRODUCTS 70604 LOT CODE 26080916 WERE WHAT WAS INSIDE THE PACKAGING".

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT HISTORY RECORDS INDICATES PRODUCTS WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN TWO OTHER EVENTS FOR THE LOT REFERENCED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED: "PRODUCTS 170706-1 WERE ORDERED AND WHAT IS LISTED ON THE PACKAGING BUT PRODUCTS 70604 LOT CODE 26080916 WERE WHAT WAS INSIDE THE PACKAGING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195814 TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY NPJ MAKO SURGICAL CORP. 12371116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other