BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA POROUS 2 PEG TIBIAL COMPONENT

    MDR report key: 4810464 · Received June 1, 2015

    Report

    Report Number
    1822565-2015-00786
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    April 28, 2015
    Report Date
    June 9, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT IDENTIFIED NO DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATION OF THE TIBIAL COMPONENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ALTHOUGH A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED, THE CLINICAL OUTCOME IS SIMILAR TO THAT FOR A FIELD ACTION TAKEN ON (B)(6) 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 FIELD ACTION HAS BEEN REPORTED TO THE FDA UNDER (B)(4). THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. THE SUPPLEMENTAL INFORMATION INCLUDING OPERATIVE NOTES AND LABELS, XRAYS, AND PICTURES WAS REVIEWED. REVISION SURGICAL NOTES INDICATE THE PATIENT WAS REVISED FOR ASEPTIC LOOSENING. INTRA-OPERATIVELY, THERE APPEARED TO BE SOME MICRO-MOTION OF THE TIBIAL COMPONENT, WHICH WAS REMOVED WITH VARIOUS SAWS. AT LEAST 40%, MAYBE UP TO 50% OF THE INFERIOR SURFACE OF THE TIBIAL COMPONENT HAD FIBROUS INGROWTH. THE PEGS WERE WELL FIXED AND APPEARED TO HAVE AN ABUNDANT AMOUNT OF BONY INGROWTH. PHOTOGRAPHS TAKEN IMMEDIATELY AFTER REMOVAL SHOW OBVIOUS BONY INGROWTH ON THE PEGS BUT NONE ON THE BACKSIDE OF THE TIBIAL COMPONENT. THE PHOTOCOPY OF AN X-RAY TAKEN (B)(6) 2014, AND LIKELY MARKED BY THE SURGEON, HIGHLIGHTS GAPS BETWEEN THE TIBIAL COMPONENT AND THE TIBIA IN THE CENTRAL AND MEDIAL REGIONS. A FIELD ACTION WAS CONDUCTED ON (B)(6) 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. AN 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 FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE FOLLOWING HAVE BEEN AMENDED: REPORT DATE, DEVICE AVAILABLE FOR EVALUATION?, CONCOMITANT MEDICAL PRODUCTS, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, AND ADDITIONAL MFR NARRATIVE. CONCOMITANT MEDICAL PRODUCTS: ITEM# 42522000610, PERSONA CR ARTICULAR SURFACE, LOT 62470499. ITEM# 42502807002 , PERSONA CR POROUS FEMORAL COMPONENT, LOT 62525346. ITEM# 00587806538, NEXGEN TM PATELLA, LOT # 62536481. RECEIVED BUT NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. FAILURE MODE WAS THAT OF FUNCTIONAL-LOSS OF INTEGRATION. INSPECTION OF THE DEVICE NOTED THAT THE PEGS WERE CUT AND THAT THE REAR SIDE OF THE TIBIA SHOWED FOREIGN MATERIAL, DISTAL (POLISHED) SURFACE WAS SCRATCHED / GOUGED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE REMAINS UNCHANGED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND POSSIBLE LOOSENING OF THE TIBIA COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352857 PERSONA POROUS 2 PEG TIBIAL COMPONENT OIY OIY ZIMMER, INC. N/A 62463701

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention