BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 5-9MM

    MDR report key: 5399572 · Received January 29, 2016

    Report

    Report Number
    3005985723-2016-00045
    Event Type
    Injury
    Date Received
    January 29, 2016
    Date of Event
    December 14, 2015
    Report Date
    January 5, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ADDED TO THIS REPORT AFTER SUBMISSION OF THE INITIAL REPORT: MCK TIBIAL BASEPLATE-RM/LL-SZ 5, CAT# 180615, LOT# 14140509, MCK FEMORAL-RM-LL-SZ 5, OFL, CAT# 180515, LOT# 26140610. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVENT REGARDING INFECTION INVOLVING A MCK TIBIAL ONLAY INSERT-SZ 5-9MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE DEVICE IS DAMAGED ON THE INFERIOR SIDE DUE TO ATTEMPT AT IMPLANTATION. MACHINE MARKINGS ARE STILL PRESENT. THERE ARE NO SIGNS OF DELAMINATION OR DISCOLORATION NOR SIGNS OF PREMATURE WEAR OBSERVED ON THE DEVICE. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE MADE AVAILABLE. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED AND THE STERILE LOT. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DR. (B)(6) INFORMED ME THAT HE HAD TO EXPLANT A 4 YEAR OLD MAKO PKA (MEDIAL UNI). THIS WAS DUE TO AN INFECTION THAT OCCURRED AFTER DENTAL WORK. HE SAID THE IMPLANTS WERE NOT LOOSE MALPOSITIONED WHEN HE REMOVED THEM. HOWEVER THERE WAS SOME PREMATURE WEAR (OR SO HE THOUGHT) ON THE POLY. AS OF THE TIME OF REMOVAL THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    DR. (B)(6) INFORMED ME THAT HE HAD TO EXPLANT A (B)(6) OLD MAKO PKA (MEDIAL UNI). THIS WAS DUE TO AN INFECTION THAT OCCURRED AFTER DENTAL WORK. HE SAID THE IMPLANTS WERE NOT LOOSE MALPOSITIONED WHEN HE REMOVED THEM. HOWEVER THERE WAS SOME PREMATURE WEAR (OR SO HE THOUGHT) ON THE POLY. AS OF THE TIME OF REMOVAL THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56616 MCK TIBIAL ONLAY INSERT-SZ 5-9MM KNEE IMPLANT NPJ MAKO SURGICAL CORP. 12221110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention