BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

    MDR report key: 13565358 · Received February 19, 2022

    Report

    Report Number
    1038671-2022-00208
    Event Type
    Injury
    Date Received
    February 19, 2022
    Date of Event
    January 31, 2022
    Report Date
    March 31, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159144
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: LOGIC CR FEMORAL POR, LEFT, SZ 2.5 (CAT# 02-010-04-0225 / SERIAL#: (B)(4)). LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T (CAT# 02-012-45-2525 / SERIAL# : (B)(4)). THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL#: (B)(4)). LOGIC CR FEMORAL POR, RIGHT, SZ 2.5 (CAT# 02-010-04-0325 / SERIAL#: (B)(4)). LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T (CAT# 02-012-45-2525 / SERIAL#: (B)(4)). LOGIC TIBIAL INSERT STD, SZ 2.5, 9 MM (CAT# 02-012-47-2509 / SERIAL#: (B)(4)). THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL#: (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS D9, G3, G6, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF AXIAL ROTATION MISMATCH OF THE FEMORAL COMPONENT RELATIVE TO THE TIBIAL INSERT AND THIRD BODY WEAR, WHICH LED TO WEAR OF THE POLYETHYLENE. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE WEAR AND DELAMINATION MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "PROSTHESIS WEAR¿ IS ASSOCIATED WITH MATERIAL DAMAGE TO A SURFACE, USUALLY INVOLVING PROGRESSIVE LOSS OR DISPLACEMENT OF MATERIAL, DUE TO RELATIVE MOTION BETWEEN THAT SURFACE AND A CONTACTING SUBSTANCE OR SUBSTANCES. SECTION D4: SERIAL NUMBER, EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) # SECTION H4: DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, B5, B6, & B7 H7. RECALL YES [NUMBER WAS REPORTED IN H9].

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT SIDE TKA, THIS (B)(6) Y/O FEMALE PATIENT HAD A REVISION DUE TO INCREASE WEAR OF THE POLYETHYLENE INSERT. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA THE LEGAL DEPARTMENT- [REVISION RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2022] THERE WERE NO POST OPERATIVE COMPLICATIONS, AND SHE WAS DISCHARGED THE NEXT DAY AND ATTENDED PHYSIOTHERAPY AND HYDROTHERAPY. BY THE END OF (B)(6) 2022, THE PATIENT NOTICED SIGNIFICANT IMPROVEMENT IN HER SYMPTOMS WITH SUBSIDENCE OF PAIN, STIFFNESS AND SWELLING IN THE RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437177 LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM UNK 10885862159144

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention