BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM

    MDR report key: 16762842 · Received April 18, 2023

    Report

    Report Number
    1038671-2023-00721
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    January 24, 2023
    Report Date
    December 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862063991
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: CONCOMITANTS: 1909312 200-02-32 - THREE PEG PATELLA 32MM 1907240 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T 99325 203-97-14 - ZIMMER SERIES 11-3729-01 3 VERSIPOWER PL 90X25X1 1903616 244-02-03 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, LEFT 1916374 244-23-09 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM.

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0019-2022. 1038671-2024-05109, 1038671-2024-05108 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-05109, 1038671-2024-05108. D10: CONCOMITANTS: (B)(6), 200-02-32 - THREE PEG PATELLA 32MM, (B)(6), 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T, (B)(6), 203-97-14 - ZIMMER SERIES 11-3729-01 3 VERSIPOWER PL 90X25X1, (B)(6), 244-02-03 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, LEFT, (B)(6), 244-23-09 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, FEMORAL LOOSENING, AND TIBIAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. 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. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED VIA THE LEGAL DEPARTMENT A 64 Y/O FEMALE PATIENT HAD A TOTAL LEFT KNEE REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 12 YEARS AND 1 MONTH LATER THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. (B)(6) 2023 V SIMMS, RN- REVISION OP REPORT OF (B)(6) 2023 OP REPORT STATES RIGHT KNEE-THE STICKER SHEET OF REVISION DEVICES SHOW 2 LEFT DEVICES AND OTHER INFORMATION, INCLUDING THE DISCHARGE SUMMARY CLEARLY INDICATE THAT THE LEFT KNEE WAS REVISED. PRE-PROCEDURE DIAGNOSIS: TKA ASEPTIC LOOSENING, TKA WEAR OF ARTICULAR BEARING, AND PAIN THE MEDIAL LATERAL GUTTERS WERE REESTABLISHED WITH DEBRIDEMENT OF SYNOVITIS AND SCAR TISSUE. THE POLYETHYLENE LINER WAS REMOVED WITHOUT DIFFICULTY WHICH WAS NOTED TO HAVE WEAR AND DISCOLORATION. THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND DISIMPACTED OFF THE DISTAL FEMUR WITHOUT DIFFICULTY. THE TIBIAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND DISIMPACTED OFF THE TIBIAL PLATEAU WITHOUT DIFFICULTY. THE PATELLA WAS NOTED TO HAVE EXCELLENT TRACKING. DRESSINGS WERE APPLIED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. DISCHARGED FROM HOSPITAL ON (B)(6) 2023 TO HOME TO FOLLOW UP WITH PCP AND SPECIALIST. PATIENT CONDITION UPON DISCHARGE: FAIR. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033021 OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM UNK 10885862063991

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H SEE H10.