BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCK PATELLOFEMORAL- L- SZ 6

    MDR report key: 4796504 · Received May 26, 2015

    Report

    Report Number
    3005985723-2015-00086
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 1, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE LOT WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 18-OCT-2011. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE DEVICE WAS RECEIVED FOR EVALUATION INSIDE THE INNER STERILE BLISTER PACK. WHITE PARTICULATE DEBRIS WAS OBSERVED ON THE CLEAR PLASTIC OF THE BLISTER PACK AND ON THE SURFACE OF THE IMPLANT. THE EVENT WAS CONFIRMED. THE INVESTIGATION CONCLUDED THE REPORTED PRODUCT AND ISSUE TO BE WITHIN THE SCOPE OF LEGACY MAKO CAPA INITIATED TO ADDRESS DEBRIS OBSERVED IN THE INNER STERILE BLISTER PACKS OF PATELLOFEMORAL IMPLANTS. THE PACKAGING DESIGN WAS UPDATED AS A CORRECTIVE ACTION FOR THE ISSUE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    DR. (B)(6) WAS PERFORMING AN ISOLATED PF PROCEDURE. THE CASE PROCEEDED NORMALLY THROUGH BONE PREPARATION. AFTER TRAILING A SIZE 6L PF COMPONENT AND 35 PATELLA THE ACTUAL IMPLANTS WERE VISUALIZED BY THE SURGICAL TEAM AND OPENED FOR THE CIRCULATING NURSE. UPON PHYSICAL EVALUATION OF THE SIZE 6 LEFT PF IMPLANT, THE CIRCULATING NURSE NOTED THAT THE IMPLANT SEEMED TO HAVE A COATING ON IT. (ITEM NUMBER 180406 LOT 23130911-01). IT WAS NOTED THAT THE IMPLANT DID SEEM TO HAVE A FILM ON IT. PRIOR TO OPENING THE SECOND "INNER" PACKAGE OF THE ORIGINAL IMPLANT, WE OBTAINED A SECOND IMPLANT AND OPENED THIS IMPLANT TO THE CIRCULATING NURSE. (ITEM NUMBER 180406 LOT 364360-M) UPON VISUAL INSPECTION, THE SAME "FILM" OR POWDER WAS NOTED ON THIS IMPLANT. HAVING ONLY THESE TWO IMPLANTS, THE DECISION WAS MADE TO USE THE ORIGINAL IMPLANT (ITEM NUMBER 180406 LOT 26130911-01) TO COMPLETE THE CASE. PRIOR TO IMPLANTING THE COMPONENT WAS THOROUGHLY WASHED WITH A SOLUTION OF BACITRACIN AND NORMAL SALINE. AFTER WASHING THE IMPLANT WAS VISUALLY INSPECTED FOR DEBRIS AND NONE WERE NOTED. THE IMPLANT WAS THEN IMPLANTED PER STANDARD PROCEDURE AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE. SALES REP PROVIDED THAT SURGICAL DELAY WAS 3 MINUTES.

    Description of Event or Problem · 1

    DR. (B)(6) WAS PERFORMING AN ISOLATED PF PROCEDURE. THE CASE PROCEEDED NORMALLY THROUGH BONE PREPARATION. AFTER TRAILING A SIZE 6L PF COMPONENT AND 35 PATELLA THE ACTUAL IMPLANTS WERE VISUALIZED BY THE SURGICAL TEAM AND OPENED FOR THE CIRCULATING NURSE. UPON PHYSICAL EVALUATION OF THE SIZE 6 LEFT PF IMPLANT, THE CIRCULATING NURSE NOTED THAT THE IMPLANT SEEMED TO HAVE A COATING ON IT. (ITEM NUMBER (B)(4) LOT 23130911-01). IT WAS NOTED THAT THE IMPLANT DID SEEM TO HAVE A FILM ON IT. PRIOR TO OPENING THE SECOND ¿INNER¿ PACKAGE OF THE ORIGINAL IMPLANT, WE OBTAINED A SECOND IMPLANT AND OPENED THIS IMPLANT TO THE CIRCULATING NURSE. (ITEM NUMBER (B)(4) LOT 364360-M) UPON VISUAL INSPECTION, THE SAME ¿FILM¿ OR POWDER WAS NOTED ON THIS IMPLANT. HAVING ONLY THESE TWO IMPLANTS, THE DECISION WAS MADE TO USE THE ORIGINAL IMPLANT (ITEM NUMBER (B)(4) LOT 26130911-01) TO COMPLETE THE CASE. PRIOR TO IMPLANTING THE COMPONENT WAS THOROUGHLY WASHED WITH A SOLUTION OF BACITRACIN AND NORMAL SALINE. AFTER WASHING THE IMPLANT WAS VISUALLY INSPECTED FOR DEBRIS AND NONE WERE NOTED. THE IMPLANT WAS THEN IMPLANTED PER STANDARD PROCEDURE AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE. SALES REP PROVIDED THAT SURGICAL DELAY WAS 3 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340613 MCK PATELLOFEMORAL- L- SZ 6 IMPLANT NPJ MAKO SURGICAL CORP. 23130911-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other