BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH TIB ROT COMP XS-XL

    MDR report key: 2950953 · Received February 8, 2013

    Report

    Report Number
    0002249697-2013-00592
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K002552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RELEASED BY HOSPITAL.

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT AND IS THEREFORE CONSIDERED CONCOMITANT. THE SUPER AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FROM 2010 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING LOOSENING. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS HAD MULTIPLE KNEE SURGERIES FOR INFECTION OR LOOSENING PER SURGEONS RECORDS. THIS TIME SHE FELL AND MOST LIKELY LOOSENED BOTH THE FEMUR AND TIBIA. WHEN SHE FELL IN 2011 HER FRACTURED TIBIA WAS PLATED. SURGERY COMPLETED ON (B)(6) 2013 AND BOTH THE FEMUR AND TIBIA WERE LOOSE AND REPLACED WITH ANOTHER MRH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS HAD MULTIPLE KNEE SURGERIES FOR INFECTION OR LOOSENING PER SURGEONS RECORDS. THIS TIME SHE FELL AND MOST LIKELY LOOSENED BOTH THE FEMUR AND TIBIA. WHEN SHE FELL IN 2011 HER FRACTURED TIBIA WAS PLATED. SURGERY COMPLETED ON (B)(6) 2013 AND BOTH THE FEMUR AND TIBIA WERE LOOSE AND REPLACED WITH ANOTHER MRH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53747 MRH TIB ROT COMP XS-XL IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH 018750

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention