BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL BASEPLATE-RM/LL-SZ 5

    MDR report key: 6912784 · Received October 3, 2017

    Report

    Report Number
    3005985723-2017-00472
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    August 28, 2017
    Report Date
    December 26, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: MCK TIBIAL ONLAY INSERT-SZ 5-8MM; CAT#: 180705-1; LOT#: 12010216-1. MCK FEMORAL-RM-LL-SZ 5; CAT#: 180515; LOT#: 26040815-01. MCK PATELLOFEMORAL-R-SZ 4; CAT#: 180414; LOT#: 2310651-1. MCK PATELLA RESURFACING ROUND DOME-29MM; CAT#: 180320-2; LOT#: 12520315-1. 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. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A MAKO BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION WERE NOT PERFORMED AS THE ITEM WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO INDICATED THAT "NO CLINICAL OR PAST MEDICAL HISTORY AND NO DOCUMENTED POST-OPERATIVE FOLLOW-UP OR DESCRIPTION OF SYMPTOMS ARE AVAILABLE FOR REVIEW. LATERAL KNEE PAIN LIKELY REPRESENTS PROGRESSION OF ARTHRITIS IN THE NON-REPLACED COMPARTMENT OF THE RIGHT KNEE. THERE IS NO EVIDENCE THAT FACTORS ASSOCIATED WITH DESIGN, MANUFACTURING OR MATERIALS OF THE IMPLANTED COMPONENTS ARE RESPONSIBLE FOR THE SYMPTOMS DESCRIBED IN THE EVENT DESCRIPTION." DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THIS LOT. CONCLUSIONS: IT WAS REPORTED THAT PATIENT HAD OCCASIONAL LATERAL KNEE PAIN & ANTERIOR FAT PAD IMPINGEMENT AFTER EXCESSIVE WEIGHT BEARING IN RIGHT KNEE. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT INFORMATION WAS PROVIDED. THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO INDICATED THAT NO CLINICAL OR PAST MEDICAL HISTORY AND NO DOCUMENTED POST-OPERATIVE FOLLOW-UP OR DESCRIPTION OF SYMPTOMS ARE AVAILABLE FOR REVIEW. LATERAL KNEE PAIN LIKELY REPRESENTS PROGRESSION OF ARTHRITIS IN THE NON-REPLACED COMPARTMENT OF THE RIGHT KNEE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT REPORTS OCCASIONAL LATERAL KNEE PAIN AND ANTERIOR FAT PAD IMPINGEMENT AFTER EXCESSIVE WEIGHT BEARING ON THEIR RIGHT KNEE.

    Description of Event or Problem · 1

    PATIENT REPORTS OCCASIONAL LATERAL KNEE PAIN AND ANTERIOR FAT PAD IMPINGEMENT AFTER EXCESSIVE WEIGHT BEARING ON THEIR RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692669 MCK TIBIAL BASEPLATE-RM/LL-SZ 5 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 26071215-01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other