BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 22459386 · Received July 9, 2025

    Report

    Report Number
    1038671-2025-02452
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    January 21, 2025
    Report Date
    November 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041302
    PMA / PMN Number
    K932690
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITTANTS: (B)(6) 232-03-04 - (DISC) OPTETRAK ASY, CR POROUS FEMORAL, SZ 4, R. (B)(6) 200-04-44 - (DISC) CEMENTED FINNED T IB. TRA SZ 4F/4T. (B)(6) 21-0901-19Y-V1 - STRYKER LPI S7/6/5/4 H.SIERRA 90*13/21*1,19. (B)(6) 200-02-29 - ROTULA TRES TETONES 29MM. (B)(6) 21-0901-19Y-V1 - STRYKER LPI S7/6/5/4 H.SIERRA 90*13/21*1,19. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6, H9, H10, H11. NO DEVICE WAS RETURNED FOR EVALUATION; RADIOGRAPH IMAGES WERE PROVIDED; HOWEVER, THE REPORTED EVENT WAS ABLE TO BE CONFIRMED IN PART. PRE-REVISION RADIOGRAPHS REVIEW IDENTIFIED WHAT APPEARED TO BE A GAP BETWEEN THE ANTERIOR FLANGE OF THE FEMORAL COMPONENT AND THE FEMORAL BONE. ADDITIONALLY, THERE APPEARS TO BE LUCENCIES NEAR BONE CONTACTING SURFACE AND THE MEDIAL SIDE OF THE FEMORAL COMPONENT, AS WELL AS THE ANTERIOR BONE CONTACTING SURFACE AND MEDIAL SIDE OF THE TIBIAL TRAY, WHICH IS CONSISTENT WITH OSTEOLYSIS. THIS INDICATES THAT THERE IS FEMORAL LOOSENING AND POSSIBLE TIBIAL LOOSENING. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, MAY HAVE LED TO LOOSENING AT THE CEMENT-IMPLANT AND/OR CEMENT-BONE INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. THE GAP BETWEEN THE FEMORAL COMPONENT AND THE TIBIAL TRAY APPEARS TO BE SLIGHTLY SMALLER IN THE PRE-REVISION RADIOGRAPH COMPARED TO THE POST INDEX RADIOGRAPH. THIS MAY INDICATE WEAR OF THE TIBIAL INSERT; HOWEVER, THIS CANNOT BE CONFIRMED AS IMAGES OF THE EXPLANTED TIBIAL INSERT WERE NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO FEMORAL LOOSENING OR DUE TO THE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. THIS SPECIFIC TIBIAL INSERT WAS PACKAGED FOR APPROXIMATELY 5.06 YEARS BEFORE BEING IMPLANTED. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, MAY HAVE LED TO LOOSENING AT THE CEMENT-IMPLANT AND/OR CEMENT-BONE INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. PROSTHESIS WEAR OF THE TIBIAL INSERT COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 72 YO MALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 9 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. IT WAS INDICATED THERE WAS PREMATURE WEAR OF THE POLYETHELYNE, WITH MECHANICAL LOOSENING OF THE IMPLANT SECONDARY TO MASSIVE OSTEOLYSIS. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AND NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702794 OPTETRAK PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862041302

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention SEE H11.