BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA TRABECULAR METAL CRUCIATE RETAINING POROUS FEMORAL COMPONENT

    MDR report key: 6033921 · Received October 17, 2016

    Report

    Report Number
    0001822565-2016-03584
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    October 9, 2017
    Report Date
    December 3, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    PMA / PMN Number
    PK122745
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENTS INVOLVED WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. OPERATIVE NOTES FROM THE PRIMARY SURGERY STATE THAT THE PATIENT UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS; HOWEVER, ONLY THE FIRST PAGE OF THE OPERATIVE NOTES WAS PROVIDED AND THE DESCRIPTION OF THE PROCEDURE WAS NOT INCLUDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. OPERATIVE NOTES FROM THE REVISION SURGERY STATES THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. THE FEMORAL COMPONENT WAS NOTED TO BE EASILY REMOVED WITH MINIMAL BONE LOSS USING THE OSCILLATING SAW AND RETROGRADE IMPACTION. A CAVITARY LESION WAS NOTED IN THE MEDIAL FEMORAL CONDYLE AFTER REMOVED THE IMPLANT. THE TIBIAL COMPONENT WAS NOTED TO HAVE GOOD INGROWTH THROUGHOUT THE TRAY AND THE PEGS. THE PATELLAR COMPONENT WAS NOTED TO BE WELL FIXED AND WAS NOT REVISED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS- NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE G, CATALOG # 42530007902, LOT # 62186997. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT 13 MM HEIGHT, CATALOG # 42521200613, LOT # 62292753. ALL POLY PATELLA CEMENTED 35 MM DIAMETER, CATALOG # 42540000035, LOT # 62299458.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO KNEE ARTHROPLASTY REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE DUE TO INSTABILITY AND PAIN. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAS A CAVITARY LESION IN THE MEDIAL FEMORAL CONDYLE. THE FEMORAL COMPONENT WAS NOTED TO BE EASILY REMOVED. OPERATIVE NOTES ALSO INDICATED THAT THE PATIENT HAS JOINT EFFUSION, PERIARTICULAR SOFT TISSUE SWELLING, AND TINY METALLIC FOREIGN BODY IN THE DISTAL RIGHT FEMORAL METAPHYSIS.

    Description of Event or Problem · 1

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686435 PERSONA TRABECULAR METAL CRUCIATE RETAINING POROUS FEMORAL COMPONENT KNEE PROSTHESIS OIY ZIMMER, INC. 62432352

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other