BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM ASSEMBLY

    MDR report key: 6761162 · Received August 2, 2017

    Report

    Report Number
    0001825034-2017-05497
    Event Type
    Injury
    Date Received
    August 2, 2017
    Date of Event
    June 20, 2015
    Report Date
    August 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PN/I
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM BEARING, UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL, UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM ASSEMBLY, UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM TIBIAL TRAY, UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL STEM, UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM TIBIAL STEM, UNKNOWN PATELLA. CUSTOMER HAS NOT INDICATED IF THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-054495/05496/05497/05498/05499/05500/05501. BEREND, K. R., & LOMBARDI, A. V. (2008). DISTAL FEMORAL REPLACEMENT IN NONTUMOR CASES WITH SEVERE BONE LOSS AND INSTABILITY. CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, 467(2), 485-492. DOI:10.1007/S11999-008-0329-X (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE THE STUDY REPORTED 4 DEEP VEIN THROMBOSIS FROM EARLY SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542505 UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM ASSEMBLY NI KRO BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other