BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAEDIC SALVAGE SYSTEM FEMORAL

    MDR report key: 6926956 · Received October 7, 2017

    Report

    Report Number
    0001825034-2017-08161
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    March 17, 2013
    Report Date
    November 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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: ORTHOPAEDIC SALVAGE SYSTEM TIBIAL BEARING, CAT#: 150410, LOT#: 090030; ORTHOPAEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT, CAT#: 150469, LOT#: 094000; ORTHOPAEDIC SALVAGE SYSTEM CEMENTED PROXIMAL TIBIAL STEM, CAT#: 150445, LOT#: 752970; ORTHOPAEDIC SALVAGE SYSTEM INTRAMEDULLARY PLUG, CAT#: 130611, LOT#: 234730; ORTHOPAEDIC SALVAGE SYSTEM POLYETHYLENE LOCK PIN, CAT#: 150478, LOT#: 932810; ORTHOPAEDIC SALVAGE SYSTEM AXLE, CAT#: 150480, LOT#: 314640; ORTHOPAEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING, CAT#: 150476, LOT#: 025760; ORTHOPAEDIC SALVAGE SYSTEM REINFORCED YOKE, CAT#: 150493, LOT#: 156880; ORTHOPAEDIC SALVAGE SYSTEM POLYETHYLENE FEMORAL BUSHING, CAT#: 150477, LOT#: 896570; BALL TIP GUIDE WIRE, CAT#: 469060; LOT#: 257058 . 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: 0001825034-2017-08162, 0001825034-2017-08163, 0001825034-2017-08164, 0001825034-2017-08165, 0001825034-2017-08166, 0001825034-2017-08167, 0001825034-2017-08168, 0001825034-2017-08169, 0001825034-2017-08170. 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
    705838 ORTHOPAEDIC SALVAGE SYSTEM FEMORAL PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 973160

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R