BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA POROUS 2 PEG TIBIAL COMPONENT

    MDR report key: 6021020 · Received October 12, 2016

    Report

    Report Number
    0001822565-2016-03664
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 25, 2014
    Report Date
    July 20, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 7 CATALOG# 42500606201 LOT# 62586009. ALL POLY PATELLA CEMENTED 35 MM DIAMETER CATALOG# 42540000035 LOT# 62617086. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT 12 MM HEIGHT CATALOG# 42512400712 LOT # 62720721. PALACOS R 1X40 SINGLE CATALOG# 00111214001 LOT# 78434385. PALACOS R 1X40 SINGLE CATALOG# 00111214001 LOT# 78654386. PATELLA REAMER BLADE WITH PILOT HOLE 46 MM DIAMETER SINGLE USE ONLY CATALOG# 00597909546 LOT# 62666909. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. OPERATIVE NOTES FROM THE INITIAL PROCEDURE WERE PROVIDED FOR FURTHER EVALUATION. THE PROCEDURE WAS INDICATED FOR OSTEOARTHRITIS AND OSTEOPHYTE FORMATION PROXIMAL TO THE KNEE. THE ANTERIOR AND POSTERIOR CRUCIATE LIGAMENTS WERE EXCISED AND OSTEOPHYTES WERE REMOVED. THE PROVISIONAL COMPONENTS WERE INSERTED AND PLACED THROUGH A RANGE OF MOTION TEST WITH EXCELLENT STABILITY NOTED. THE TIBIA WAS PRESS FIT INTO POSITION WHILE THE FEMUR AND PATELLA WERE CEMENTED IN. ONCE BONE CEMENT WAS HARDENED, THE KNEE WAS PLACED INTO A FINAL RANGE OF MOTION AND STABILITY WAS NOTED TO BEING EXCELLENT AGAIN. NO ADVERSE REACTIONS NOTED DURING THE PROCEDURE. DEVICE HISTORY RECORD 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 WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDRS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE REFERENCE: 3007963827-2016-00065, 0001822565-2016-03664, 0001822565-2016-03665, 0002648920-2016-03212.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING AN UNKNOWN ISSUE AFTER A LEFT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674157 PERSONA POROUS 2 PEG TIBIAL COMPONENT KNEE PROSTHESIS OIY ZIMMER, INC. N/A 62519918

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other