BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA TAPERED STEM EXTENSION

    MDR report key: 6175681 · Received December 15, 2016

    Report

    Report Number
    0001822565-2016-04666
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 15, 2016
    Report Date
    February 26, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    PMA / PMN Number
    PK133737
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT:- TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C CATALOG#: 42532006401 LOT#: 63365514, PALACOS R 1X40 SINGLE CATALOG#: 00111214001 LOT#: 78034369, ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT 20 MM HEIGHT CATALOG#: 42511400420 LOT#: 63003580, FEMUR CEMENTED POSTERIOR STABILIZED (PS) NARROW LEFT SIZE 5 CATALOG#:42500005801 LOT#: 62305208, INSET ALL POLY PATELLA CEMENTED 26 MM DIAMETER CATALOG#: 42540000026 LOT#: 62803701. COMPLAINT SAMPLE AND X RAYS WERE EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PATELLA, LINER, AND FEMORAL CONTACT SURFACES EXHIBIT SIGNS OF WEAR AND SCRATCHING. THE STEM AND EXTENSION WERE BOUND TOGETHER DUE TO EXCESSIVE BONE CEMENT. REVIEW OF X-RAYS CONCLUDED: "LOOSENING OF THE TIBIAL COMPONENT. VARUS ALIGNMENT OF THE TIBIAL COMPONENT MAY BE DUE TO SURGICAL PLACEMENT VERSUS POSSIBLE MIGRATION/SUBSIDENCE SINCE IMPLANTATION DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-04664, 0001822565 - 2017 - 06288.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PERSONA PS ARTICULAR SURFACE, ITEM # 42511400420, LOT # 63003580. PERSONA STEMMED TIBIAL COMPONENT, ITEM # 42532006401, LOT # 63365514.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY REVISION, THE PATIENT WAS AGAIN REVISED FOR TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827148 PERSONA TAPERED STEM EXTENSION KNEE PROSTHESIS OIY ZIMMER, INC. N/A 63376521

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R