BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSONA POROUS PEGGED TIBIAL COMPONENT

    MDR report key: 4990498 · Received August 7, 2015

    Report

    Report Number
    1822565-2015-01445
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    July 13, 2015
    Report Date
    September 13, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    Removal / Correction Number
    Z-1266-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE ARTICULAR SURFACE DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATION OF THE ARTICULAR SURFACE. PRIMARY OPERATIVE NOTES INDICATE THAT RANGE OF MOTION AND STABILITY WERE FOUND TO BE EXCELLENT THROUGHOUT WITH WELL-BALANCED GAPS AND ACCEPTABLE TRACKING OF THE PATELLA. OPERATIVE NOTES FROM THE REVISION SURGERY WERE NOT RECEIVED. REPORTED INFORMATION INDICATES THAT THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. PER THE PERSONA SYSTEM PACKAGE INSERT, JOINT INSTABILITY IS A KNOWN RISK OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRIMARY OPERATIVE NOTES CONFIRMS THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO A SEVERE DEGENERATIVE KNEE DISEASE. TRIALS WERE INSERTED AND THE RANGE OF MOTION AND STABILITY WERE CHECKED. UPON THE RELEASE OF A FEW LIGAMENTS, ACCEPTABLE EXTENSION AND FLEXION WAS ACHIEVED. THERE WERE WELL-BALANCED GAPS AND EXCELLENT TRACKING OF THE PATELLA. THE FINAL COMPONENTS WERE PUT IN WITH A CEMENTLESS TECHNIQUE. RANGE OF MOTION AND STABILITY WERE RECHECKED AND WERE EXCELLENT THROUGHOUT WITH WELL-BALANCED GAPS AND ACCEPTABLE TRACKING OF THE PATELLA. REVIEW OF THE REVISION OPERATIVE NOTES CONFIRMS THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. UPON REMOVAL OF THE TIBIAL COMPONENT, IT WAS FOUND THAT ONE OF THE PEGS WAS 50% FIBROUS UNDERSURFACE WITH REMAINING BEING GOOD BONY INGROWTH. THE FINAL PEG HAD ABOUT 90% BONY INGROWTH. THE NEW FINAL COMPONENT WAS CEMENTED INTO PLACE. A FIELD ACTION WAS CONDUCTED ON FEBRUARY 19, 2015 IN WHICH ZIMMER VOLUNTARILY REMOVED THE PERSONA TRABECULAR METAL TIBIAL IMPLANT FROM THE FIELD DUE TO A HIGHER THAN ANTICIPATED COMPLAINT RATE FOR RADIOLUCENT LINES AND LOOSENING. THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION. FDA RECALL Z-1266-2015 CONTAINS THE RELATED TIBIAL LOT NUMBER. THE CAPA INVESTIGATION DETERMINED THAT THE LIKELY ROOT CAUSES FOR THE HIGHER THAN ANTICIPATED COMPLAINT RATE ARE THAT THE PERSONA TM TIBIA ALLOWS THE POTENTIAL FOR THE TIBIAL IMPLANT TO SIT PROUD ON THE RESECTED TIBIAL SURFACE AND THE PERSONA TM TIBIA HAS LESS INITIAL STABILITY THAN PREDICATE DEVICES. THEREFORE, RECEIVING THE OPERATION NOTES CHANGED THE PREVIOUS INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION DUE TO PAIN AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521123 PRSONA POROUS PEGGED TIBIAL COMPONENT OIY ZIMMER, INC. 62452049

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention