BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 5754648 · Received June 28, 2016

    Report

    Report Number
    0001822565-2016-02195
    Event Type
    Injury
    Date Received
    June 28, 2016
    Report Date
    February 2, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK042271
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ZIMMER NEXGEN FEMORAL COMPONENT, CATALOG #: 00-5996-015-52, LOT #: 62976890. ZIMMER NEXGEN TIBIAL COMPONENT, CATALOG #: 00-5980-037-02, LOT #: 62928171. ZIMMER PERSONA PATELLA CATALOG #: 42-5400-000-35, LOT #: 62869346. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS IS REPORT 3 OF 4 FOR THIS PATIENT. SEE ALSO 3007963827-2016-00047-2, 0002648920-2016-00905-2, AND 0002648920-2016-00906-2. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT, ARTICULAR SURFACE, AND PATELLAR COMPONENT IDENTIFIED NO DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT IDENTIFIED ONE ANOMALY DUE TO A UNIT BEING FOUND OVERSIZED IN OPERATION 100 (MACHINE COMPLETE AND DEBURR). THE AFFECTED UNIT WAS SCRAPPED DUE TO THE THREAD BEING OUT OF SPECIFICATION. THIS ANOMALY WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE TIBIAL COMPONENT ALSO HAD A DEVIATION DUE TO A WATER PIPE BREAK AT THE PONCE FACILITY, WHICH CAUSED THE CLEAN ROOM PARAMETERS TO BE OUT OF THE ESTABLISHED RANGES. AS A RESULT, THIS LOT WAS REWORKED WITH ADDED OPERATIONS AFTER OPERATION 2500 TO REPLACE THE POLY SUBCOMPONENTS AND INSPECT. THE LOT PROCEEDED THROUGH NORMAL PROCESSING AFTER THE REWORK. THIS DEVIATION WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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. REVIEW OF THE IMPLANTED DEVICES IDENTIFIED NO COMPATIBILITY ISSUES. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. PER THE NEXGEN CR, PS, CRA, LPS, AND LCCK PACKAGE INSERT, SWELLING OR INFECTION ARE KNOWN RISKS OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS FURTHER REPORTED THAT THE PATIENT UNDERWENT TWO ADDITIONAL PROCEDURES FOR DRAINAGE OF THE SURGICAL SITE, REMOVAL OF SCAR TISSUE, AND MANIPULATION OF THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, STIFFNESS, INFECTION, LIMITED RANGE OF MOTION, LIMPING AND NOISE FROM THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409121 NEXGEN LPS-FLEX ARTICULAR SURFACE KNEE PROSTHESIS MBH ZIMMER, INC. 62247472

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R