BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK FEMORAL-RM-LL-SZ 6

    MDR report key: 5493718 · Received March 10, 2016

    Report

    Report Number
    3005985723-2016-00081
    Event Type
    Injury
    Date Received
    March 10, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 16, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO PAIN INVOLVING A MCK FEMORAL-RM-LL-SZ 6 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION COULD NOT BE PERFORMED AS THE SUBJECT DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODES WERE IDENTIFIED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED PAIN DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. PAIN CAN OCCUR POST-OPERATIVELY FOR A NUMBER OF REASONS AND IS A SYMPTOM RATHER THAN THE CAUSE OF THE ISSUE THE PATIENT IS EXPERIENCING. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICE WAS ALSO LISTED IN THIS REPORT: MCK TIBIAL BASEPLATE-RM/LL-SZ 7; CAT# 180617; LOT# 26100713-01. MCK TIBIAL ONLAY INSERT-SZ 7-8MM; CAT# 180707-1; LOT# 12080114-3. 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 NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT HAD A MEDIAL MAKO IN (B)(6) 2014 AND COMPLAINS OF LATERAL KNEE PAIN.

    Description of Event or Problem · 1

    PATIENT HAD A MEDIAL MAKO IN (B)(6) 2014 AND COMPLAINS OF LATERAL KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148827 MCK FEMORAL-RM-LL-SZ 6 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 2047371-1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention