BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA POROUS 2 PEG TIBIAL COMPONENT

    MDR report key: 4934621 · Received July 21, 2015

    Report

    Report Number
    1822565-2015-01255
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    September 21, 2015
    Report Date
    June 23, 2015
    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

    NO DEVICES RETURNED FOR EVALUATION. PRIMARY SURGICAL NOTES DO NOT INDICATE DEVIATIONS OR ANOMALIES DURING SURGERY. REVISION NOTES STATE THAT THE PATIENT HAS A "FAILED RIGHT TOTAL KNEE ARTHROPLASTY." ONLY THE TIBIAL COMPONENT WAS REMOVED AS THE FEMORAL AND PATELLAR COMPONENTS "WERE WELL FIXED." THE CONDITION OF TIBIAL COMPONENT WAS NOT NOTED. 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. THIS TIBIAL COMPONENT WAS IMPLANTED PRIOR TO THIS FIELD ACTION. THIS FIELD ACTION HAS BEEN REPORTED TO THE FDA AND THE RECALL NUMBER IS Z-1266-2015. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. SURGICAL NOTES WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PRODUCT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE PRODUCTS AND THE PHOTOGRAPHS CONFIRMS THAT THE PERSONA TM TIBIA HAD SCRATCHES AND GOUGES ON THE PROXIMAL SURFACE AND AROUND THE EDGES. THE TM SURFACE OF THE TIBIA IDENTIFIED BONE INGROWTH AND THE PEGS WERE CUTOFF DURING EXTRACTION. THE ARTICULAR SURFACE HAD GOUGES ON THE LATER CONDYLAR SURFACE AND AROUND THE LOCKING RAILS ON THE DISTAL SURFACE. IT WAS ALSO NOTED THAT THE DOVETAIL FEATURE HAD FLARED OUT WHICH IS LIKELY THE RESULT OF REMOVAL OF THE IMPLANT. BASED ON THE INFORMATION PROVIDED, PREVIOUS CONCLUSION SUMMARY AND DETAIL ARE NOT AFFECTED AND REMAIN THE SAME.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND IS SCHEDULED FOR REVISION SURGERY.

    Description of Event or Problem · 1

    IT IS FURTHER REPORTED THAT THE PATIENT WAS REVISED DUE TO A LOOSE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470712 PERSONA POROUS 2 PEG TIBIAL COMPONENT OIY ZIMMER, INC. 62559160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R