BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGN PS HIGH FLEX XLPE SZ 7-8 11MM

    MDR report key: 8661506 · Received June 2, 2019

    Report

    Report Number
    1020279-2019-02139
    Event Type
    Injury
    Date Received
    June 2, 2019
    Date of Event
    May 9, 2019
    Report Date
    October 22, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556035153
    PMA / PMN Number
    K071071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS RETURNED AND EVALUATED. THE LAB ANALYSIS CONCLUDED, THE TIBIAL INSERT SHOW THE CONDITION OF THE COMPONENT, LOCK DETAIL APPEARS DAMAGED, AND DEFORMATIONS ON THE ANTERIOR SURFACES AND SUPERIOR SURFACES INCLUDING A CRACK ON THE ANTERIOR SUPERIOR SURFACE INTERSECTION WERE OBSERVED. THE POST OF THE INSERT WAS FRACTURED AND ADRIFT FROM THE REST OF THE INSERT COMPONENT. ANTERIOR VIEW, FRACTURED POST AND DEFORMATION ON THE UPPER LEFT CORNER OF THE SUPERIOR SURFACE. THE LEFT SIDE LOCK DETAIL AND SUPERIOR OUTER CORNER SIDES OF THE COMPONENT APPEAR DAMAGED IN THE BLUE RECTANGLES. THE POST IS FRACTURED. POSTERIOR POST SURFACES IN BLUE CIRCLES APPEAR DAMAGED. THERE IS A CRACK IN THE ANTERIOR SUPERIOR CORNER IN THE BLUE SQUARE. THE RIGHT SIDE LOCK DETAIL AND SUPERIOR POSTERIOR CORNER ARE DAMAGED. THE RIGHT SIDE OF FRACTURED POST SHOWS DAMAGE IN THE BLUE CIRCLE. THE EXACT CAUSES OF OBSERVED DAMAGE COULD NOT BE DETERMINED FROM THE INVESTIGATION OF THE DEVICE. THERE WERE NO OBSERVATIONS OF MATERIAL OR MANUFACTURING DEVIATIONS IN THE COURSE OF THIS INVESTIGATION. A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE CORRESPONDING PRODUCTS DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES/FAILURE MODE. THE CLINICAL/MEDICAL TEAM CONCLUDED, WITHOUT THE REQUESTED CLINICAL INFORMATION A THOROUGH MEDICAL INVESTIGATION CANNOT BE RENDERED. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WOULD BE RE-ASSESSED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AGO, PATIENT FELT A POP AND UNSTEADINESS WITH HIS KNEE AFTER GETTING UP FROM KNEELING AND BENDING. UPON OBSERVATION, THE POST OF THE POLYETHYLENE HAS SHEARED OFF. HOSPITAL PATHOLOGY IS IN POSSESSION OF THE DAMAGED IMPLANT. SURGEON IS REQUESTING A COPY OF THE REPORT. A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454733 LGN PS HIGH FLEX XLPE SZ 7-8 11MM PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. 10GM14724 00885556035153

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R