BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA POROUS TWO PEG TIBIAL COMPONENT

    MDR report key: 5195221 · Received November 2, 2015

    Report

    Report Number
    1822565-2015-02272
    Event Type
    Injury
    Date Received
    November 2, 2015
    Date of Event
    October 6, 2015
    Report Date
    June 8, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    OIY
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRIMARY OPERATIVE NOTES CONFIRMS THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO SEVERE DEGENERATIVE JOINT DISEASE OF THE RIGHT KNEE. FINAL COMPONENTS DISPLAYED EXCELLENT RANGE OF MOTION, STABILITY WITH WELL BALANCED GAPS, AND ACCEPTABLE TRACKING OF THE PATELLA WHILE USING THE NO THUMB TECHNIQUE. REVIEW OF THE REVISION OPERATIVE NOTES CONFIRMS THE PATIENT UNDERWENT A REVISION FOR SYMPTOMS CONSISTENT WITH A FAILED RIGHT TOTAL KNEE ARTHROPLASTY. DURING SURGERY, THE PATIENT WAS FOUND TO HAVE SIGNIFICANT SUBSIDENCE OF THE TIBIAL COMPONENT. UPON REMOVAL THE TIBIAL IMPLANT WAS FOUND TO HAVE POSTERIOR SUBSIDENCE OF AT LEAST 2-3 MM. THE DETAILS FROM THE OPERATIVE NOTES STILL TIE IN TO THE REASONS FOR THE FIELD ACTION PREVIOUSLY REPORTED, SO THE ROOT CAUSE HAS NOT CHANGED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES- ZIMMER PERSONA CRUCIATE RETAINING (CR) ARTICULAR SURFACE VIVACIT-E HIGHLY CROSSLINKED POLYETHLENE 14MM FEM 3-11 TIB EF RIGHT CATALOG# 42-5220-005-14 LOT# 62828140, ZIMMER PERSONA CRUCIATE RETAINING NARROW POROUS FEMORAL COMPONENT SIZE 8 RIGHT CATALOG# 42-5022-060-02 LOT# 62795823, ZIMMER NEXGEN PRIMARY POROUS PATELLA 35MM X 10MM CATALOG# 00-5878-065-35, LOT# 62756981. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. IT WAS NOTED THAT THE PEGS WERE CUT AND SLIGHTLY SCRATCHED MARKS ON THE POLISHED SIDE OF THE TIBIAL SURFACE. THE FEMORAL COMPONENT AND POLY LINER WERE ALSO RETURNED. A SMALL AMOUNT OF WEAR WAS OBSERVED ON THE TOPSIDE OF THE LINER. SURFACE SCRATCHES WERE OBSERVED ON THE POLISHED SIDE OF THE FEMORAL COMPONENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE WAS DETERMINED TO BE A PREVIOUSLY ADDRESSED DESIGN ISSUE. 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). NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT WERE REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS/ANOMALIES IDENTIFIED. THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATION OF TIBIAL COMPONENT RELATED TO THE EVENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENT WAS IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A SAGITTAL X-RAY IMAGE TAKEN TWO MONTHS PRIOR TO THE REVISION SURGERY SHOWS WHAT APPEARS TO BE A POSTERIOR TILT OF THE TIBIAL PLATE AND A GAP IN THE ANTERIOR REGION BETWEEN THE TIBIAL PLATE AND THE TIBIA. 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 CORRECTIVE AND PREVENTIVE ACTION 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.

    Description of Event or Problem · 1

    REVISION DUE TO LOOSENING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725531 PERSONA POROUS TWO PEG TIBIAL COMPONENT OIY OIY ZIMMER INC 62620494

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention