BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SUFACE PROLONG HIGLY CROSSLINKED POLYETHYLENE

    MDR report key: 7077687 · Received December 2, 2017

    Report

    Report Number
    0001822565-2017-08273
    Event Type
    Injury
    Date Received
    December 2, 2017
    Date of Event
    April 16, 2016
    Report Date
    December 8, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042271
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT: 00598005701 61916238 TIBIAL COMPONENT STEMMED PRECOAT USE OF THIS TIBIAL COMPONENT WITH LEGACY KNEE - CONSTRAINED CONDYLAR KNEE (LCCK) ARTICULATING SURFACES REQUIRES USING 00596401752 61849036 FEMORAL COMPONENT OPTION SIZE G RIGHT COMPATIBLE WITH LPS-FLEX PROLONG 00597206638 61733263 ALL POLY PATELLA STANDARD SIZE 38 MM DIAMETER 9.5 MM THICKNESS FOR CEMENTED USE ONLY. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. PER THE PACKAGING INSERT FOR THE ARTICULAR SURFACE, SWELLING OR INFECTION AND LOOSENING OR FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS OR SURROUNDING TISSUES ARE CONSIDERED TO BE KNOWN ADVERSE EFFECTS OF THE PROCEDURE. THE ROOT CAUSE CANNOT BE DETERMINED USING PROVIDED 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2017-00220, 0001822565 - 2017 - 08272.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S KNEE WAS REVISED APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO INFECTION AND LOOSENING OF COMPONENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. OPERATIVE NOTES INDICATED THE BONE UNDERLYING THE FEMORAL AND TIBIAL PROSTHESIS WAS SOFT, PARTICULARLY ON THE LATERAL SIDE. THERE WAS ALSO A COPIOUS AMOUNTS OF FLUID, TISSUE, BONE CULTURE, AND GRAM STAINED FROM THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856797 ARTICULAR SUFACE PROLONG HIGLY CROSSLINKED POLYETHYLENE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 61233328

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R