BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGN PS HIGH FLEX XLPE SZ 3-4 11MM

    MDR report key: 8765820 · Received July 6, 2019

    Report

    Report Number
    1020279-2019-02624
    Event Type
    Injury
    Date Received
    July 6, 2019
    Date of Event
    June 25, 2019
    Report Date
    November 25, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556034170
    PMA / PMN Number
    K071071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A SECOND STAGE REVISION WAS PERFORMED DUE TO INFECTION AND LOOSENING. THE ASSOCIATED LEGION OXINIUM CONSTRAINED FEMORAL COMPONENT, LEGION REVISION TIBIAL BASEPLATE, GENESIS II BICONVEX PATELLAR COMPONENT, LEGION POS FEMORAL WEDGE, AND LEGION PRESSFIT STEM WERE NOT RETURNED FOR EVALUATION. THUS A PRODUCT EVALUATION COULD NOT BE PERFORMED. HOWEVER, DEVICE DETAILS WERE PROVIDED. THUS, THE REVIEW OF THE MANUFACTURING RECORDS FOR THE LISTED BATCHES DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. A REVIEW OF THE COMPLAINT HISTORY FOR THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED FAILURE MODE WITH THE SAME BATCH NUMBER. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THE LIMITED INFORMATION PROVIDED, THE CLINICAL ANALYSIS NOTED THE SECOND REVISION WAS MOST LIKELY DUE TO A LATENT INFECTION/RECURRENCE. THE PATIENT IMPACT BEYOND THE REVISION PROCEDURE AND EXPECTED MEDICAL INTERVENTIONS FOR INFECTION CANNOT BE DETERMINED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER SMITH AND NEPHEW WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECOND STAGE REVISION WAS PERFORMED DUE TO INFECTION AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559497 LGN PS HIGH FLEX XLPE SZ 3-4 11MM PROSTHSIS,KNEE,PTELLOFEMOROTIBIL,SMICONSTRAIND,CMENTD, POLYMER/METAL/POLYMER JWH SMITH & NEPHEW, INC. 16BT65735 00885556034170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R