BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM

    MDR report key: 14824552 · Received June 26, 2022

    Report

    Report Number
    1038671-2022-00722
    Event Type
    Injury
    Date Received
    June 26, 2022
    Date of Event
    December 30, 2021
    Report Date
    November 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144423
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS. LOGIC CR FEMORAL CEM, LEFT SZ 1.5 (CAT# 02-010-03-0215 / SERIAL# 4412158) THREE PEG PATELLA 29MM (CAT# 200-02-29 / SERIAL# 5307110) LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T (CAT# 02-012-45-1515 / SERIAL# 4231840) ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED BY LEGAL BRIEF, PATIENT'S INITIAL TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2018. PATIENT'S UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 DUE TO PREMATURE FAILURE OF HIS EXACTECH OPTETRAK TOTAL KNEE DEVICE. NO ADDITIONAL INFORMATION AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; NO REASON FOR REVISION WAS GIVEN. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION RECEIVED FROM LEGAL BRIEF INDICATES THAT DURING REVISION SURGERY, PATIENT¿S SURGEON STATED, ¿WE WERE ABLE TO LEVER THE POLYETHYLENE PLASTIC WITH A SMALL OSTEOTOME AND AFTER THIS WAS RETRIEVED, WE THEN INSPECTED THE PLASTIC, NOTED TO HAVE PITTING AND DELAMINATION OF THE MEDIAL ASPECT OF THE TIBIAL POLYETHYLENE. OTHERWISE, THE POLYETHYLENE LOOKED TO BE IN GOOD CONDITION LATERALLY¿. DESPITE UNDERGOING REVISION SURGERY, PATIENT EXPERIENCE DAILY PAIN AND DISCOMFORT IN PATIENT¿S LEFT KNEE WHICH LIMITS PATIENT¿S ACTIVITIES OF DAILY LIVING AND IMPACTS PATIENT¿S QUALITY OF LIFE. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF WEAR OF THE TIBIAL INSERT. HOWEVER, THE CAUSE OF THE WEAR COULD NOT BE DETERMINED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION AND IMAGES WERE NOT PROVIDED. ADDITIONALLY, THE INSERT WAS PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED WEAR. 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

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT,. ASSOCIATED REPORT: 1038671-2024-04477. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, LOOSENING AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL BRIEF, PATIENT'S INITIAL TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2018. PATIENT'S UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 DUE TO PREMATURE FAILURE OF HIS EXACTECH OPTETRAK TOTAL KNEE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267256 LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM UNK 10885862144423

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention