BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM YOKE

    MDR report key: 7065834 · Received November 28, 2017

    Report

    Report Number
    0001825034-2017-10630
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    September 9, 2015
    Report Date
    December 17, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ORTHOPEDIC SALVAGE SYSTEM BEARING, CATALOG #: 150413, LOT #: 845190; ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHING, CATALOG #: 150477, LOT #: 163300; ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING, CATALOG #: 150476, LOT #: 073450; ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN, CATALOG #: 150478, LOT #: 890580; ORTHOPEDIC SALVAGE SYSTEM AXLE, CATALOG #: 150480, LOT #: 780600; ORTHOPEDIC SALVAGE SYSTEM PATELLA, CATALOG #: 184788, LOT #: 256080. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-10625, 0001825034-2017-10626, 0001825034-2017-10627, 0001825034-2017-10628, 0001825034-2017-10629. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR UNKNOWN REASONS. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845073 ORTHOPEDIC SALVAGE SYSTEM YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 423260

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R