BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 11MM

    MDR report key: 17691058 · Received September 6, 2023

    Report

    Report Number
    1038671-2023-02166
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    February 21, 2023
    Report Date
    November 8, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862064080
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF THE INVESTIGATION, THE FOLLOWING FIELDS HAVE BEEN UPDATED: D1, D4, D10, G4, G4, H6, H7, AND H9. D10. CONCOMITANTS: (B)(6), 200-02-35 - THREE PEG PATELLA 35MM. (B)(6), 200-04-55 - CEMENTED FINNED TIB. TRA SZ 5F/5T . (B)(6), 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK). (B)(6), 203-90-01 - 11-2624 POWERPRO SAWBLADE. (B)(6), 244-02-05 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 5, LEFT. H6. INVESTIGATION RESULTS - THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF POLYETHYLENE WEAR, INSTABILITY AND LOOSENING AS STATED IN THE LEGAL DOCUMENTATION. THE ASEPTIC (NON-INFECTED) LOOSENING MAY HAVE BEEN THE RESULT OF BOTH PATIENT-RELATED CONDITIONS AND INSUFFICIENT BONDS BETWEEN THE IMPLANTS AND THE BONES. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS, PHOTOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 244-25-11 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 11MM. (B)(6), 200-02-35 - THREE PEG PATELLA 35MM. (B)(6), 200-04-55 - CEMENTED FINNED TIB. TRA SZ 5F/5T. (B)(6), 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK). (B)(6), 203-90-01 - 11-2624 POWERPRO SAWBLADE. (B)(6), 244-02-05 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 5, LEFT. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2007. APPROXIMATELY 15 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES: PAIN, SUFFERING, AND INSTABILITY IN HIS LEFT KNEE. THE COMPONENTS OF HIS IMPLANT WERE NOTED TO BE GROSSLY LOOSE AND WERE REPLACED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454785 OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862064080

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SEE H10| SEE H10.