BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 3, 13MM

    MDR report key: 11474822 · Received March 12, 2021

    Report

    Report Number
    1038671-2021-00108
    Event Type
    Injury
    Date Received
    March 12, 2021
    Date of Event
    January 18, 2021
    Report Date
    May 15, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054265
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION NOTED THAT REVISION REPORTED WAS LIKELY THE RESULT OF THE SPINE STIFFENING SCREW BACKING OUT OF THE TIBIAL STEM EXTENSION, WHICH ULTIMATELY RESULTED IN INSTABILITY. HOWEVER, THE REASON FOR THE SCREW DISENGAGEMENT COULD NOT BE DETERMINED AS THE EXPLANTS WERE NOT AVAILABLE FOR EVALUATION AND X-RAYS WERE NOT PROVIDED. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "DISASSEMBLED / MISASSEMBLED" IS ASSOCIATED WITH THE UNWANTED DISASSEMBLY OF THE DEVICE, OR INCORRECT ASSEMBLY OF THE DEVICE (ATTACHING MATING INSTRUMENTATION INCORRECTLY, ASSEMBLING AN IMPLANT CONSTRUCT OFF-AXIS, ETC.). SECTION : BRAND NAME SECTION : MODEL NUMBER, CATALOG NUMBER, SERIAL NUMBER, EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) # SECTION : DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS CEMENTED TRAPEZOID TRAY (CAT# 204-04-34 / SERIAL# (B)(4). FEM. STEM EXT. ADAPTER 5 (CAT# 208-09-05 / SERIAL# (B)(4). THREE PEG PATELLA, 38MM (CAT# 200-02-38 / SERIAL# (B)(4). CCK TIBIAL INSERT SIZE 3, 13MM (CAT# 208-23-13 / SERIAL# (B)(4). 3'' TROCAR, MOD. HEX (CAT# 201-78-81 / SERIAL# (B)(4). HOLDING PIN MINI SHARP POINT (CAT# 201-78-15 / SERIAL# (B)(4). 3'' DRILL BIT (CAT# 201-78-89 / CAT# (B)(4). 3'' TROCAR, MOD. HEX (CAT# 201-78-81 / SERIAL# (B)(4). HOLDING PIN HEADLESS 3 (CAT# 201-46-10 / SERIAL# (B)(4). POST. FEMORAL AUGMENT SZ 3, 5 MM (CAT# 208-07-03 / SERIAL# (B)(4). DISTAL FEMORAL AUGMENT SZ 3, 10 MM (CAT# 208-06-03 / SERIAL# (B)(4). STEM EXTENSION 80 X 18 MM (CAT# 204-38-08 / SERIAL# (B)(4). DISTAL FEMORAL AUGMENT SZ 3, 10 MM (CAT# 208-06-03 / SERIAL# (B)(4). STEM EXTENSION W/SLOT 120 X 16 MM (CAT# 204-36-12 / SERIAL# (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 8 YRS POSTOP THE INITIAL IMPLANT, THE RIGHT CCK LINER WAS REPLACED BY A NEW CCK IMPLANT IN THIS THIS MALE PATIENT. SURGEON SUSPECTED THAT IT IS THE BACKING OF THE STUFFING SCREW CAUSED THE COMPONENTS TO SEPARATE DURING RANGE OF MOTION AND RESULT IN INSTABILITY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT RETURNING FOR EVALUATION DUE TO HOSPITAL DISPOSED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373775 CC TIBIAL INSERT SZ 3, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. CC TIBIAL INSERT SZ 3, 13MM UNK 10885862054265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S