BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA POROUS 2 PEGGED TRABECULAR METAL TIBIAL COMPONENT

    MDR report key: 5278165 · Received December 9, 2015

    Report

    Report Number
    1822565-2015-02611
    Event Type
    Injury
    Date Received
    December 9, 2015
    Date of Event
    December 30, 2015
    Report Date
    February 6, 2019
    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 Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4). THE DEVICES REMAIN IMPLANTED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE PART AND LOT NUMBER IS 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCT: NEXGEN COMPLETE KNEE SOLUTION STANDARD PRIMARY PATELLA ¿ CAT. NO. NOT PROVIDED; LOT NO. 62593968, FEMUR CR NRW ¿ CAT. NO. 42-5022-064-02; LOT NO. 62621307, ARTICULAR SURFACE ¿ CAT. NO. 42-5220-005-10; LOT NO. 62342604 . REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. REVIEW OF THE REVISION OPERATIVE NOTES INDICATES THAT THE PATELLA AND FEMUR FOUND TO BE WELL FIXED BUT THE TIBIA WAS FOUND TO BE LOOSE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE PROBLEM WITH THIS DEVICE CONSTITUTES A "DESIGN ISSUE" AS THE ROOT CAUSE. 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 SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EVALUATION OF THE RETURNED TIBIAL COMPONENT FOUND THAT ITS SUPERIOR SURFACE WAS GOUGED AND DISCOLORED. THE TWO PEGS WERE STILL ATTACHED TO THE INFERIOR SURFACE AND REMNANT OF A FOREIGN SUBSTANCE (BONE CEMENT) WAS UNEVEN, ESPECIALLY IT WAS NOT PRESENT ON THE HEXAGONAL SIDES OF THE PEGS 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 NOW KNOWN THAT THE PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY REVISION DUE TO TIBIAL LOOSENING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING RESTRICTION AND PAIN WHEN BENDING HER KNEE. X-RAYS REPORTEDLY SHOW THAT THE IMPLANT HAS PULLED AWAY FROM THE BONE. REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2015.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806899 PERSONA POROUS 2 PEGGED TRABECULAR METAL TIBIAL COMPONENT KNEE PROSTHESIS MBH ZIMMER INC 62490330

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O| R