BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC PRIM FIXED FEM COMP TC PS RIGHT 8 CEM

    MDR report key: 10497503 · Received September 4, 2020

    Report

    Report Number
    9613369-2020-00168
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    July 22, 2020
    Report Date
    December 11, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JWH
    PMA / PMN Number
    K000666
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E1 RESULTS OF INVESTIGATION: IT WAS REPORTED THAT TC PLUS FEMORAL COMPONENT WAS REVISED DUE TO BREAKAGE AND WEAR OF THE EFK TIBIA INLAY (LEGAL MANUFACTURER OHST). THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR INVESTIGATION. THE PRODUCTION DOCUMENTATION REVIEW DID NOT REVEAL ANY DEVIATION FROM STANDARD PROCEDURES. A CLINICAL ASSESSMENT COULD NOT BE PERFORMED, AS NO DOCUMENTATION WAS PROVIDED. THE COMPLAINT HISTORY WAS REVIEWED, THERE WERE NO FURTHER COMPLAINTS REPORTED IN THE PAST FOR THE BATCH IN SCOPE. THE COMBINATION OF THE TC PLUS FEMORAL COMPONENT AND THE EFK TIBIA COMPONENTS FROM LEGAL MANUFACTURER OHST IS NOT APPROVED BY SMITH AND NEPHEW. TO WHAT EXTENT THIS COMBINATION CONTRIBUTED TO THE REPORTED FAILURE CANNOT BE ASSESSED. ABRASION OF IMPLANT SURFACES ARE LISTED AMONG THE POSSIBLE SIDE EFFECTS OF KNEE IMPLANTS IN THE IFU (LIT. NO. 12.24 ED. 07/10). THE REPORTED FAILURE MODE IN COVER THROUGH THE RISK MANAGEMENT. BASED ON THE AVAILABLE INFORMATION THE ROOT CAUSE FOR THE REPORTED WEAR CANNOT BE DETERMINED. FURTHERMORE, THE FAILURE MODE CANNOT BE CONFIRMED. AT THIS TIME, NO FURTHER ACTION ARE DEEMED NECESSARY. SHOULD ADDITIONAL INFORMATION OR THE PRODUCT BECOME AVAILABLE, THIS COMPLAINT WILL BE REASSESSED. SMITH AND NEPHEW WILL MONITOR THE DEVICE FOR FURTHER SIMILAR ISSUES. LEGAL MANUFACTURER OHST WAS INFORMED BY SMITH AND NEPHEW ABOUT THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO MATERIAL FAILURE WITH FRACTURE OF THE INLAY AND SEVERE INLAY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960723 TC PRIM FIXED FEM COMP TC PS RIGHT 8 CEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW ORTHOPAEDICS AG 0511.13.7114

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EFK INSERT (THIRD PARTY)| EFK INSERT (THIRD PARTY)