BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 3 - 10 MM

    MDR report key: 7285547 · Received February 21, 2018

    Report

    Report Number
    3005985723-2018-00081
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    January 24, 2018
    Report Date
    April 2, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    PMA / PMN Number
    K150307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 3; CAT# 180513; LOT# 491964-M. MCK TIBIAL BASEPLATE-RM/LL-SZ 3; CAT# 180613; LOT# 26070616-01. MCK PATELLOFEMORAL-R-SZ 3; CAT# 180613; LOT# 2405191-1. MCK PATELLA RESURFACING ROUND DOME-29MM; CAT# 180320-2 LOT# 12230515-1. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE FOLLOWING DEVICE¿S CATALOG# WAS INCORRECT AND HAVE BEEN UPDATED: 3. MCK PATELLOFEMORAL-R-SZ 3; CAT# 180413; LOT# 2405191-1. AN EVENT REGARDING PAIN INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED AND THE DEVICE WAS NOT RETURNED. FURTHER INFORMATION SUCH AS PRODUCT EVALUATION, PRE- AND POST-OPERATIVE X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. 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

    PATIENT HAD A MAKO UNI AND PATELLA FEMORAL REPLACEMENT ON (B)(6) 2017 AND RECENTLY PRESENTED WITH PERSISTENT PAIN. DOCTOR REMOVED IMPLANTS AND REVISED WITH A TOTAL KNEE.

    Description of Event or Problem · 1

    PATIENT HAD A MAKO UNI AND PATELLA FEMORAL REPLACEMENT ON (B)(6) 2017 AND RECENTLY PRESENTED WITH PERSISTENT PAIN. DOCTOR REMOVED IMPLANTS AND REVISED WITH A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130217 MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 3 - 10 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ STRYKER ORTHOPAEDICS-MAHWAH RJ2EHA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R