BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-L-SZ 4

    MDR report key: 5147180 · Received October 14, 2015

    Report

    Report Number
    3005985723-2015-00195
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    September 16, 2015
    Report Date
    September 16, 2015
    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

    AN EVENT REGARDING A REVISION SURGERY INVOLVING A MAKO PATELLA COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: "THERE IS NO EVIDENCE THAT THE CONVERSION OF THE PATELLOFEMORAL ARTHROPLASTY TO A TOTAL KNEE ARTHROPLASTY DUE TO PROGRESSION OF ARTHRITIS WAS RELATED TO FACTORS OF FAULTY PATELLOFEMORAL DESIGN, MANUFACTURING OR MATERIALS." DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS MANUFACTURING LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES AND THE RETURN OF THE DEVICES ARE NEEDED TO COMPLETE THE INVESTIGATION. IT WAS ALSO CONCLUDED THAT THERE IS NO INDICATION THE EVENT IS RELATED TO A MANUFACTURING ISSUE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DR. (B)(6) PERFORMED A REVISION SURGERY. HE REVISED A PATIENT THAT HAD A LEFT KNEE MAKO PF REPLACEMENT ON (B)(6) 2014 TO AN EXACTECH CEMENTED PRIMARY TOTAL KNEE DUE TO DISEASE PROGRESSION TO THE MEDIAL AND LATERAL COMPARTMENTS.

    Description of Event or Problem · 1

    DR. (B)(6) PERFORMED A REVISION SURGERY. HE REVISED A PATIENT THAT HAD A LEFT KNEE MAKO PF REPLACEMENT ON (B)(6) 2014 TO AN EXACTECH CEMENTED PRIMARY TOTAL KNEE DUE TO DISEASE PROGRESSION TO THE MEDIAL AND LATERAL COMPARTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680078 MCK PATELLOFEMORAL-L-SZ 4 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 26080912-02

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention