BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGN PS HIGH FLEX XLPE SZ 5-6 9MM

    MDR report key: 5920917 · Received September 1, 2016

    Report

    Report Number
    1020279-2016-00682
    Event Type
    Injury
    Date Received
    September 1, 2016
    Date of Event
    June 23, 2014
    Report Date
    May 3, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K071071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICES WERE NOT RETURNED FOR EVALUATION. THE PROVIDED CLINICAL REPORTS INDICATED THERE WAS NO INFECTION, AS EVIDENCED BY THE SAMPLES SENT TO PATHOLOGY DURING THE 1ST AND 2ND STAGE REVISION; THEREFORE THE ALLEGED SEVERE INFECTION CANNOT BE SUPPORTED. THE PATHOLOGY OF SYNOVECTOMY TISSUE SHOWED ¿BLACK PIGMENTED FOREIGN BODY MATERIAL¿ WHICH IS CONSISTENT WITH METAL ON METAL (MOM) WEAR, HOWEVER THE ROOT CAUSE OF THE PE INSERT DISPLACEMENT AND MOM CONTACT BETWEEN THE FEMORAL CONDYLES AND THE TIBIAL BASEPLATE CANNOT BE CONFIRMED. PER REVIEW OF PROVIDED INFORMATION, IT IS POSSIBLE THAT A COMBINATION OF THE PATIENT¿S COMORBID CONDITIONS, EARLY OVERLOADING OF R KNEE IN THE POST-OP PHASE, POSSIBLE PROSTHESIS WEAR AND/OR DISLOCATION, AND THE REPORTED NEOPLASM/HETEROTOPIC BONE FORMATION CONTRIBUTED TO THE REPORTED EVENTS OF THE DISPLACED PE INSERT AND ASSOCIATED METAL ON METAL WEAR, FIBROSIS AND PAIN. THE PATIENT WAS DISCHARGED TO A SNF TO CONTINUE PT/OT REHABILITATION AND LATER EXPERIENCED COMPLICATIONS WITH THE COMPETITOR TKA COMPONENTS INCLUDING A ¿BROKE PROSTHETIC JOINT IMPLANT¿, FB GRANULOMA AND CHRONIC INFECTIONS PER PROVIDED DOCUMENTATION. NO FURTHER MEDICAL ASSESSMENT CAN BE PROVIDED AT THIS TIME. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ALL DEVICES WERE STERILIZED ACCORDING TO QUALITY DOCUMENTATION. A REVIEW OF COMPLAINT HISTORY REVEALED THAT WE HAVE NOT HAD ANY PREVIOUS COMPLAINTS FOR THE LISTED BATCHES, OTHER THAN THE COMPLAINTS ASSOCIATED WITH THIS PATIENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICES WERE NOT RETURNED FOR EVALUATION. THE PROVIDED CLINICAL REPORTS INDICATED THERE WAS NO INFECTION, AS EVIDENCED BY THE SAMPLES SENT TO PATHOLOGY DURING THE 1ST AND 2ND STAGE REVISION; THEREFORE THE ALLEGED SEVERE INFECTION CANNOT BE SUPPORTED. THE PATHOLOGY OF SYNOVECTOMY TISSUE SHOWED ¿BLACK PIGMENTED FOREIGN BODY MATERIAL¿ WHICH IS CONSISTENT WITH METAL ON METAL (MOM) WEAR, HOWEVER THE ROOT CAUSE OF THE PE INSERT DISPLACEMENT AND MOM CONTACT BETWEEN THE FEMORAL CONDYLES AND THE TIBIAL BASEPLATE CANNOT BE CONFIRMED. PER REVIEW OF PROVIDED INFORMATION, IT IS POSSIBLE THAT A COMBINATION OF THE PATIENT¿S COMORBID CONDITIONS, EARLY OVERLOADING OF R KNEE IN THE POST-OP PHASE, POSSIBLE PROSTHESIS WEAR AND/OR DISLOCATION, AND THE REPORTED NEOPLASM/HETEROTOPIC BONE FORMATION CONTRIBUTED TO THE REPORTED EVENTS OF THE DISPLACED PE INSERT AND ASSOCIATED METAL ON METAL WEAR, FIBROSIS AND PAIN. THE PATIENT WAS DISCHARGED TO A SNF TO CONTINUE PT/OT REHABILITATION AND LATER EXPERIENCED COMPLICATIONS WITH THE COMPETITOR TKA COMPONENTS INCLUDING A ¿BROKE PROSTHETIC JOINT IMPLANT¿, FB GRANULOMA AND CHRONIC INFECTIONS PER PROVIDED DOCUMENTATION. NO FURTHER MEDICAL ASSESSMENT CAN BE PROVIDED AT THIS TIME. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ALL DEVICES WERE STERILIZED ACCORDING TO QUALITY DOCUMENTATION. A REVIEW OF COMPLAINT HISTORY REVEALED THAT WE HAVE NOT HAD ANY PREVIOUS COMPLAINTS FOR THE LISTED BATCHES, OTHER THAN THE COMPLAINTS ASSOCIATED WITH THIS PATIENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. IF ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY WHERE IT WAS DISCOVERED THAT THE KNEE COMPONENTS HAD FAILED AND THAT THE LEGION PS ARTICULAR INSERT WAS DISPLACED ANTERIORLY AND WAS ENCAPSULATED WITHIN A PSEUDOTUMOR AND FOREIGN BODY GRANULOMA WITH METALLOSIS. NO COMPONENTS WERE REVISED OR REMOVED FROM WHAT HAS BEEN REPORTED. GENESIS II AND LEGION KNEE IMPLANTS WERE USED IN THE INITIAL SURGERY.

    Description of Event or Problem · 1

    ALL COMPONENTS EXPLANTED. TWO STAGE REVISION WAS DECIDED INTRA-OPERATIVELY WITH THIS SURGICAL PROCEDURE INCLUDING EXCISION OF THE PSEUDOTUMOR, SYNOVECTOMY, EXPLANTATION OF ALL COMPONENTS, DEBRIDEMENT OF BONY SURFACE, IRRIGATION, PLACEMENT OF STEINMANN PINS IN FEMUR AND TIBIA AND PLACEMENT OF ANTIBIOTIC CEMENT AS SPACER IN THE KNEE JOINT. PATIENT WAS THEN CLOSED AND HIS KNEE IMMOBILISED USING KNEE IMMOBILISER. SECOND STEP REVISION CAPTURED UNDER (B)(4) - MDR 1020279-2016-00683.

    Description of Event or Problem · 1

    IT WAS DISCOVERED THAT THE KNEE COMPONENTS HAD FAILED AND WAS ENCAPSULATED WITHIN A PSEUDOTUMOR AND FOREIGN BODY GRANULOMA WITH METALLOSIS. NO COMPONENTS REPORTED REVISED OR REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573219 LGN PS HIGH FLEX XLPE SZ 5-6 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 11JM07535

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O LEGION KNEE IMPLANT