BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 2, 9MM

    MDR report key: 13122488 · Received December 30, 2021

    Report

    Report Number
    1038671-2021-00739
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    December 7, 2021
    Report Date
    April 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048226
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT MEDICAL PRODUCTS: OPTETRAK 3-PEG PATELLA.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF ROTATIONAL MISMATCH BETWEEN THE FEMORAL AND TIBIAL COMPONENTS AND PATIENT-RELATED CONDITIONS, WHICH LED TO POLYETHYLENE WEAR ON BOTH THE TIBIAL INSERT AND PATELLA AND CAUSED THE REPORTED ANTERIOR KNEE PAIN. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: LOGIC STEM EXT 12MM X 80MM (CAT# 02-012-60-1280 / SERIAL# (B)(4)); THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(4)); CC DISTAL FEM AUGMENT SZ 2, 10MM (CAT# 208-06-02 / (B)(4)); CC DISTAL FEM AUGMENT SZ 2, 10MM (CAT# 208-06-02 / SERIAL# (B)(4)); LOGIC OFFSET STEM EXT COUPLER 6MM (CAT# 02-012-61-6000 / SERIAL# (B)(4)); LOGIC POST. AUG. BLOCK SIZE 2, 10MM (CAT# 02-010-06-0522 / SERIAL# (B)(4)); LOGIC CC FEMORAL SIZE 2, LEFT (CAT# 02-010-06-0220 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME: PS TIBIAL INSERTS SZ 2, 9MM, (D4) CATALOG NUMBER: 204-22-09, UNIQUE IDENTIFIER (UDI) #: (B)(4). (D10) CONCOMITANT DEVICES: 200-02-29, (B)(6) - PATELLA. 02-012-60-1280, (B)(6) - LOGIC STEM EXT 12MM X 80MM. 208-06-02, (B)(6) - CC DISTAL FEM AUGMENT SZ 2, 10MM. 208-06-02, (B)(6) - CC DISTAL FEM AUGMENT SZ 2, 10MM. 02-012-44-2013, (B)(6) - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM. 02-012-61-6000, (B)(6) - LOGIC OFFSET STEM EXT COUPLER 6MM. 02-010-06-0522, (B)(6) - LOGIC POST. AUG. BLOCK SIZE 2, 10MM. 02-010-06-0220, (B)(6) - LOGIC CC FEMORAL SIZE 2, LEFT. (G4) PMA/510(K)NUMBER: K932690. (H3) THE REVISION REPORTED WAS LIKELY DUE TO AXIAL ROTATIONAL MISMATCH BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD-BODY WEAR, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO PROSTHESIS WEAR ON THE TIBIAL INSERT AND THE PATELLA CAUSING THE REPORTED ANTERIOR KNEE PAIN.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY SIX MONTHS POST RIGHT TKA IMPLANTATION, A (B)(6) FEMALE PATIENT HAD ANTERIOR KNEE PAIN AND A POLY AND PATELLA EXCHANGE WAS MADE. THERE WERE NO PARTS OR PIECES FELL INTO THE PATIENT WOUND AREA. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020575 PS TIBIAL INSERTS SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. OPTETRAK PS TIBIAL INSERT UNK 10885862048226

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention