BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 6-8MM

    MDR report key: 6477006 · Received April 10, 2017

    Report

    Report Number
    0002249697-2017-01172
    Event Type
    Injury
    Date Received
    April 10, 2017
    Date of Event
    March 13, 2017
    Report Date
    July 28, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK TIBIAL BASEPLATE-RM/LL-SZ 6; CAT# 180616; LOT# 26160212-01, MCK FEMORAL-RM-LL-SZ 5; CAT# 180515; LOT# 26420811-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED PAIN AND LOOSENING INVOLVING A MAKO INSERT WAS REPORTED. CONCLUSION: THERE IS NO INDICATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT HOWEVER, BASED ON THE MEDICAL REVIEW THE MOST LIKELY SOURCES OF THE ALLEGED SYMPTOMS DESCRIBED ARE ¿SOFT TISSUE IMBALANCE AND PROGRESSION OF OSTEOARTHRITIS TO THE OTHER COMPARTMENTS.¿ THE INSERT IS AN INTEGRAL PART OF THE TIBIAL COMPONENT CONSTRUCT AND WILL HAVE TO BE EXPLANTED TOGETHER WITH THE LOOSE BASEPLATE AND NO OTHER ALLEGATIONS WERE MADE AGAINST THE INSERT THEREFORE IT IS CONSIDERED AS CONCOMITANT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    RIGHT KNEE: PATIENT CALLED REGARDING BILATERAL MAKOPLASTY INSERTS, SURGERY (B)(6) 2013 BOTH. SURGERY WENT WELL. BETWEEN (B)(6) 2014 BOTH KNEES STARTED TO GET SORE. SAW SURGEON SEVERAL TIMES, XRAYS SHOWS EVERYTHING WAS FINE BUT STILL SORE, DID EXERCISE DURING PHYSICAL THERAPY. WENT TO A SECOND SURGEON FOR ANOTHER OPINION OF WHICH DURING THE PHYSICAL EXAM THE SURGEON COULD HEAR RATTLING. QUALITY OF LIFE IS DIMINISHING AS A RESULT OF HIS KNEES AND UNABLE TO WALK FOR LONG PERIODS, ESPECIALLY UP AND DOWN STAIRS. TOLD TO WEAR A BRACE WHICH HE SAYS DOESN'T HELP OR DO A REVISION SURGERY. HE STATED THAT THERE IS LOOSING.

    Description of Event or Problem · 1

    RIGHT KNEE: PATIENT CALLED REGARDING BILATERAL MAKOPLASTY INSERTS, SURGERY (B)(6) 2013 BOTH. SURGERY WENT WELL. BETWEEN (B)(6) 2014 BOTH KNEES STARTED TO GET SORE. SAW SURGEON SEVERAL TIMES, XRAYS SHOWS EVERYTHING WAS FINE BUT STILL SORE, DID EXERCISE DURING PHYSICAL THERAPY. WENT TO A SECOND SURGEON FOR ANOTHER OPINION OF WHICH DURING THE PHYSICAL EXAM THE SURGEON COULD HEAR RATTLING. QUALITY OF LIFE IS DIMINISHING AS A RESULT OF HIS KNEES AND UNABLE TO WALK FOR LONG PERIODS, ESPECIALLY UP AND DOWN STAIRS. TOLD TO WEAR A BRACE WHICH HE SAYS DOESN'T HELP OR DO A REVISION SURGERY. HE STATED THAT THERE IS LOOSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257891 MCK TIBIAL ONLAY INSERT-SZ 6-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12020213-1

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other