BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 41MM

    MDR report key: 19670495 · Received July 3, 2024

    Report

    Report Number
    1038671-2024-02304
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    October 11, 2022
    Report Date
    September 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039620
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 02-010-01-0230 - COMPOSANT FEMORAL LOGIC A CIMENTER T.3 GAUCHE. (B)(6), 02-012-45-3030 - EMBASE TIBIALE FIT LOGIC CIMENTEE 3F/3T.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. MANUFACTURER NARRATIVE UPDATED: THE PATIENT WAS REVISED FOR A RECALLED TIBIAL INSERT. THE CAUSE OF THE PATIENT'S CONDITION AS RELATED TO THE PATELLA SUBLUXATION CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE PROVIDED INFORMATION APPEARS TO INDICATE THAT THE SUBLUXATION WAS SECONDARY TO SWELLING AND NOT A MALFUNCTION OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 6 YEARS 9 MONTHS POST THE INITIAL IMPLANT PROCEDURE. CHANGE OF INSERT FOLLOWING SIGNS OF ASYMMETRICAL WEAR. INSERTS WERE IDENTIFIED AS BEING PART OF THE RECALL. CLINICAL SIGNS WERE HYDARTHROSIS, GENERAL LAXITY & SUB-LUXATION OF THE PATELLA DUE TO MAJOR SWELLING. INITIAL INSERT WAS RETRIEVED & REPLACED: THE EXPLANT SHOWED SIGNS OF ASYMMETRICAL WEAR BUT WAS NOT SHOWING SIGNS OF DELAMINATION ACCORDING TO THE SURGEON. NO BACK WEAR VISIBLE. THE INSERT WAS REPLACED WITH A 15MM PSC (INITIAL ONE WAS 13MM). THE PRODUCT RETURN STATUS IS UNKNOWN AT THIS TIME. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR CONSISTENT WITH OXIDATIVE DEGENERATION OF THE POLYETHYLENE. CONTRIBUTING FACTORS TO THE SEVERITY OF THE WEAR ON THE RETURNED TIBIAL INSERT MAY HAVE BEEN RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS AND INSTABILITY OF THE KNEE. DEVICE RECEIVED ON 11/8/2022. PHOTOS WILL SEND SEPARATELY PRODUCT RETURNING - RG597318. TIBIAL INSERT: 02-012-35-3013, INSERT TIBIAL LOGIC FIXE PS T3 13MM, (B)(6). ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K033883. PATELLAR COMPONENT: 200-02-41 - IMPLANT PATELLAIRE 3 PLOTS SERIAL: (B)(6), SERIAL NUMBER (B)(6) IS PART OF RECALL Z-2155-2024. 510K: K932690, UDI: (B)(4), PRODUCT CODE: JWH. CONCOMITANTS: (B)(6), 02-010-01-0230 - COMPOSANT FEMORAL LOGIC A CIMENTER T.3 GAUCHE. (B)(6), 02-012-45-3030 - EMBASE TIBIALE FIT LOGIC CIMENTEE 3F/3T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478467 THREE PEG PATELLA 41MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11.