BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA POROUS TWO PEG TIBIAL COMPONENT

    MDR report key: 4951529 · Received July 28, 2015

    Report

    Report Number
    1822565-2015-01334
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    October 12, 2015
    Report Date
    June 30, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    Removal / Correction Number
    Z-1266-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE PART AND LOT NUMBERS ARE UNKNOWN. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION FROM SALES REPRESENTATIVE INDICATING THAT THE PATIENT WAS REVISED DUE TO PAIN AND POSSIBLE LOOSENING OF THE TIBIAL PLATE. DEVICE HISTORY RECORDS FOR THE TIBIAL PLATE WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE FOUND. A PRODUCT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATION. 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.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED WITH COMPLAINT FOR INVESTIGATION; THEREFORE, THE CONDITION OF THE PRODUCT IS UNKNOWN AND VISUAL / DIMENSIONAL EVALUATIONS ARE NOT POSSIBLE. SURGICAL NOTES HAVE NOW BEEN PROVIDED FOR REVIEW. PER SURGICAL NOTES IT WAS STATED: THE OPERATIVE PROCEDURE WAS 30% MORE DIFFICULT DUE TO BODY MASS INDEX OF 40.3. THE PATIENT REQUIRED MUCH MORE TIME AND EFFORT IN POSITIONING THE PATIENT, FURTHER ASSISTANCE HOLDING THE RETRACTORS, EXPOSURE, AND CLOSURE OF THE SURGICAL WOUND. THE PATIENT COUNSELING INFORMATION NOTES THAT COMPLICATIONS AND/OR FAILURE OF PROSTHETIC IMPLANTS ARE MORE LIKELY TO OCCUR IN PATIENTS WITH UNREALISTIC FUNCTIONAL EXPECTATIONS, HEAVY PATIENTS, PHYSICALLY ACTIVE PATIENTS, AND/OR WITH PATIENTS WHO FAIL TO FOLLOW THROUGH WITH THE REQUIRED REHABILITATION PROGRAM. AFTER THE CUTS WERE MADE, TRIALS WERE INSERTED. RANGE OF MOTION AND STABILITY WERE CHECKED. THE PATIENT REQUIRED THE FOLLOWING RELEASES; ILIOTIBIAL BAND, LATERAL RETINACULUM. THIS FACILITATED ACCEPTABLE EXTENSION AND FLEXION. WELL-BALANCED GAPS. EXCELLENT TRACKING OF THE PATELLA. THE FINAL COMPONENTS WERE PLACED USING CEMENTLESS TECHNIQUE. RANGE OF MOTION AND STABILITY WERE RECHECKED AND FOUND TO BE EXCELLENT THROUGHOUT WITH WELL-BALANCED GAPS AND ACCEPTABLE TRACKING OF THE PATELLA USING A NO-THUMB TECHNIQUE. A PRODUCT HISTORY REPORT FOUND NO OTHER COMPLAINTS FOR THE RELATED LOT/PART NUMBERS. AS THE PATIENT WAS REVISED DUE TO POSSIBLE LOOSENING OF THE TIBIAL PLATE, IT IS NOTED THAT A FIELD ACTION WAS CONDUCTED ON FEBRUARY 19, 2015 IN WHICH ZIMMER VOLUNTARILY REMOVED THE PERSONA TRABECULAR METAL ( TM ) 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 CONTAINS THE RELATED TIBIAL LOT NUMBER. THE CORRECTIVE ACTIONS INVESTIGATION DETERMINED IT STANDS REMAINING 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.

    Description of Event or Problem · 1

    IT IS FURTHER REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, POPPING, BRUISING, TIGHTNESS, BACK PAIN AND NUMBNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490649 PERSONA POROUS TWO PEG TIBIAL COMPONENT OIY OIY ZIMMER, INC. 62407620

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R