BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA TRABECULAR METAL TIBIAL COMPONENT

    MDR report key: 6172192 · Received December 13, 2016

    Report

    Report Number
    0001822565-2016-04573
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    May 22, 2015
    Report Date
    November 3, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    Z-1266-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: PT WEIGHT - WEIGHT - NI. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE 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. THEREFORE, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION TO A TOTAL KNEE ARTHROPLASTY DUE TO LOOSENING AND FLUID COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821072 PERSONA TRABECULAR METAL TIBIAL COMPONENT KNEE PROSTHESIS OIY ZIMMER, INC. N/A 62490352

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R 00111214001 PALACOS BONE CEMENT, LOT78304383| 42502806802 PERSONA TM FEMORAL COMPONENT, 62643716| 42522200610 PERSONA ARTICULAR SURFACE, LOT62699325| 42540200041 PERSONA ALL-POLY PAETELLA, LOT62625479