BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK FEMORAL-LM-RL-SZ 5

    MDR report key: 5880823 · Received August 16, 2016

    Report

    Report Number
    3005985723-2016-00252
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    July 20, 2016
    Report Date
    July 20, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICE WAS ALSO LISTED IN THIS REPORT: MCK TIBIAL BASEPLATE-LM/RL-SZ 6; CAT# 180606; LOT# UNKNOWN. MCK TIBIAL ONLAY INSERT-SZ 6-9MM; CAT# 180706-2; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PATIENT FACTORS INVOLVING A MAKO FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL RECORDS WERE REVIEWED BY A CONSULTING CLINICIAN WHO INDICATED "THE PRIMARY HARM INVOLVED IS CONVERSION OF A PATELLOFEMORAL ARTHROPLASTY TO A TOTAL KNEE BECAUSE OF PROGRESSION OF THE PATIENT¿S PRIMARY DISEASE. IT IS NOT UNEXPECTED WHEN PERFORMING AN INDEX PATELLOFEMORAL ARTHROPLASTY THAT AT SOME POINT IN THE FUTURE THE PATIENT WILL NEED OR REQUIRE CONVERSION TO A TOTAL KNEE ARTHROPLASTY IF THEIR PRIMARY DISEASE PROGRESSES HAS OCCURRED IN THIS INSTANCE. NO IMPLANT OR MANUFACTURING DEFECT WAS IDENTIFIED IN THIS REVIEW." DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: THE PROVIDED MEDICAL RECORDS WERE REVIEWED BY A CONSULTING CLINICIAN WHO INDICATED "THE PRIMARY HARM INVOLVED IS CONVERSION OF A PATELLO-FEMORAL ARTHROPLASTY TO A TOTAL KNEE BECAUSE OF PROGRESSION OF THE PATIENT¿S PRIMARY DISEASE. IT IS NOT UNEXPECTED WHEN PERFORMING AN INDEX PATELLO-FEMORAL ARTHROPLASTY THAT AT SOME POINT IN THE FUTURE THE PATIENT WILL NEED OR REQUIRE CONVERSION TO A TOTAL KNEE ARTHROPLASTY IF THEIR PRIMARY DISEASE PROGRESSES HAS OCCURRED IN THIS INSTANCE. NO IMPLANT OR MANUFACTURING DEFECT WAS IDENTIFIED IN THIS REVIEW." THE ROOT CAUSE OF THE REPORTED REVISION SURGERY COULD NOT BE DEFINITIVELY DETERMINED. HOWEVER, THE PATIENTS INHERENT PRIMARY DISEASE IS THE MOST LIKELY CAUSE FOR THE REVISION AS PER THE CLINICIAN'S ASSESSMENT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    SURGEON REVISED A LEFT KNEE MAKO UNI ORIGINALLY DONE (B)(6) 2011 DUE TO PROGRESSIVE OA IN THE PATELLOFEMORAL JOINT TO A PRIMARY CEMENTLESS TRIATHLON.

    Description of Event or Problem · 1

    SURGEON REVISED A LEFT KNEE MAKO UNI ORIGINALLY DONE (B)(6) 2011 DUE TO PROGRESSIVE OA IN THE PATELLOFEMORAL JOINT TO A PRIMARY CEMENTLESS TRIATHLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532572 MCK FEMORAL-LM-RL-SZ 5 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention