BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM

    MDR report key: 10371209 · Received August 5, 2020

    Report

    Report Number
    1038671-2020-00375
    Event Type
    Injury
    Date Received
    August 5, 2020
    Date of Event
    February 26, 2019
    Report Date
    May 17, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF ADDITIONAL INFORMATION RECEIVED, INVESTIGATION WAS RE-RAN AND SECTION H6 WAS UPDATED. H6: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF WEAR OF THE TIBIAL INSERT AND JOINT INSTABILITY. HOWEVER, THE CAUSE AND EXTENT OF THE POSSIBLE WEAR CANNOT BE DETERMINED BECAUSE THE COMPONENT WAS NOT RETURNED TO EXACTECH FOR EVALUATION AND NO PHOTOGRAPHS OR RADIOGRAPHS WERE PROVIDED. CONTENT WAS ADDED TO THE FOLLOWING FIELD INITIALLY LEFT BLANK: D4, D8, H4, H7, AND H9.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS D4, G3, G4, G5, G7, H2 AND H3 HAVE BEEN UPDATED ACCORDINGLY. (H3) UPON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT A DESIGN OR MANUFACTURING ISSUE CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED REVISION WAS LIKELY THE RESULT OF UNDERLYING PATIENT FACTORS, WHICH LED TO INSTABILITY OF THE JOINT. PER IFU# 700-096-004 INSTABILITY IS A KNOWN COMPLICATION FOLLOWING TOTAL KNEE REPLACEMENT SURGERY AND IS MULTIFACTORIAL IN NATURE. INSTABILITY IS LISTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH TOTAL JOINT REPLACEMENT SURGERY IN THE PRODUCT IFU (700-096-004). AS NOTED IN WHY ARE TOTAL KNEE ARTHROPLASTIES FAILING TODAY¿HAS ANYTHING CHANGED AFTER 10 YEARS? (SHARKEY, P. L. (2014S, SEPTEMBER). THE JOURNAL OF ARTHROPLASTY, 29), INSTABILITY IS IN THE TOP FIVE REASONS FOR THAT ACCOUNT FOR APPROXIMATELY 85% OF TOTAL KNEE REVISIONS (7.35% OF REVISIONS ARE FOR INSTABILITY).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 27.8, UNDERWENT IMPLANTATION OF A INSERT TIB 3.5 13MM KNEE POSTSTAB MOD NET CMPR MLD LOGIC, SERIAL # (B)(4). ON (B)(6) 2019, APPROXIMATELY 33 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY (OA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830923 LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Disability| R