BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT

    MDR report key: 5910671 · Received August 29, 2016

    Report

    Report Number
    0001822565-2016-03026
    Event Type
    Injury
    Date Received
    August 29, 2016
    Date of Event
    November 28, 2016
    Report Date
    August 7, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    Z-1266-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    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

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION INDICATES THAT THE DEVICES EXHIBIT SIGNS OF WEAR (NICKED OR GOUGED). THE PEGS ARE DETACHED FROM THE TIBIAL COMPONENT. BONE CEMENT IS FOUND ON THE BOTTOM SURFACE OF THE TIBIAL COMPONENT. ROOT CAUSE DOES NOT CHANGE WITH THE ADDITIONAL INFORMATION. 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

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. PMA/510(K) NUMBER - K121771. DEVICE PRODUCT CODE - MBH. CONTACT OFFICE NAME/ADDRESS - MS. (B)(6). 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.CONCOMITANT PRODUCTS:ITEM # 42502206402, PERSONA CR TM NARROW FEMORAL, LOT # 62504843,ITEM # 42522000510, PERSONA CR VE ARTICULAR SURFACE, LOT # 62559452.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. OPERATIVE NOTES FROM THE PRIMARY SURGERY STATE THAT THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DUE TO SEVERE DEGENERATIVE JOINT DISEASE. THE FINAL COMPONENTS WERE IMPLANTED USING A CEMENTLESS TECHNIQUE. RANGE OF MOTION AND STABILITY WERE NOTED TO BE EXCELLENT THROUGHOUT WITH WELL-BALANCED GAPS. IT WAS ALSO NOTED THAT NO PATELLAR COMPONENT WAS IMPLANTED AS THE PATIENT¿S HYALINE CARTILAGE WAS NORMAL. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. OPERATIVE NOTES FROM THE REVISION SURGERY STATE THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED AND WAS NOT REVISED. IT WAS ALSO NOTED THAT THE PATIENT¿S PATELLA WAS NOTED TO BE ARTHRITIC SO IT WAS RESURFACED DURING THE REVISION SURGERY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A PREVIOUS FIELD ACTION WAS CONDUCTED 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 ROOT CAUSE FOR THIS EVENT IS 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING COMPLICATIONS IN HER RIGHT KNEE POST-OPERATIVELY.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563206 PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT KNEE PROSTHESIS MBH ZIMMER, INC. 62490330

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R