BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGN PS HIGH FLEX XLPE SZ 5-6 15MM

    MDR report key: 8348538 · Received February 18, 2019

    Report

    Report Number
    1020279-2019-00651
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    September 7, 2017
    Report Date
    June 17, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556033913
    PMA / PMN Number
    K071071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. A CLINICAL EVALUATION WAS CONDUCTED AND DETAILS REGARDING THE PATIENT¿S WEIGHT-BEARING STATUS, BONE QUALITY, AND OTHER ADDITIONAL CLINICAL RELEVANT INFORMATION HAVE NOT BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE DEVICE FOR EVALUATION AND DIAGNOSTIC IMAGES, THE ROOT CAUSE OF THE REPORTED PAIN AND LOOSENING CANNOT BE DETERMINED. HOWEVER, THE ONGOING PAIN IS LIKELY DUE TO THE LOOSENING OF THE COMPONENT, AND BASED ON THE PATIENT MEDICAL RECORDS THE PATIENT SUSTAINED MULTIPLE FALLS IN INJURIES FOLLOWING HER IMPLANTATION, THESE INJURIES CANNOT BE RULED OUT AS CONTRIBUTING FACTORS FOR LOOSENING OF THE COMPONENTS. C-0232354, C-0232483, C-0232487, C-0232492 AND C-0232355, C-0232517, C-0232521, C-0232532: ALTHOUGH IT WAS REPORTED THAT THE PATIENT HAD A KNEE ARTHROSCOPY WAS PERFORMED ON TWO DIFFERENT OCCASIONS NO PROCEDURE DOCUMENTATION HAS BEEN PROVIDED FOR REVIEW. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED SEVERAL ASPIRATIONS AND WITHOUT THE RESULTS OF THE KNEE ASPIRATIONS WE ARE UNABLE TO RULE OUT AN INFECTION AS A CONTRIBUTORY FACTOR OR THE SUTURES WHICH WERE REMOVED IN THE SECOND PROCEDURE. THE PATIENT IMPACT BEYOND THE PROCEDURES CANNOT BE DETERMINED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES WITH THE SAME FAILURE MODE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TWO UNSUCCESSFUL ASPIRATION ATTEMPTS DUE TO PAIN AND EFFUSION, A KNEE ARTHROSCOPY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140296 LGN PS HIGH FLEX XLPE SZ 5-6 15MM PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. 12DM12508 00885556033913

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R