BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM

    MDR report key: 18789599 · Received February 27, 2024

    Report

    Report Number
    1038671-2024-00329
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    September 15, 2023
    Report Date
    March 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862063991
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: CORRECTED - H6 CLINICAL CODE CHANGED FROM 1994 PAIN TO E2109 IMPLANT PAIN, MEDICAL DEVICE PROBLEM CODE 1454 PEELED/DELAMINATED CHANGED TO A051207 UNSTABLE, INVESTIGATION FINDINGS CODES 4243 AND 3252 NO LONGER APPLY, INVESTIGATION CONCLUSION CODE CHANGED FROM 22 KNOWN INHERENT RISK OF DEVICE TO D1501 CAUSE LINKED TO DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF JOINT INSTABILITY AND UNEVEN FORCE DISTRIBUTION ACROSS THE JOINT, WHICH LED TO WEAR OF THE TIBIAL INSERT. FRACTURE OF THE PATELLA WAS ALSO REPORTED BUT THE CAUSE, EXTENT, AND ORDER OF EVENTS CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. THE REVISED COMPONENT(S) WAS NOT RETURNED FOR EVALUATION AND NO RADIOGRAPHS WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04903. THE REVISION REPORTED WAS LIKELY THE RESULT OF JOINT INSTABILITY AND UNEVEN FORCE DISTRIBUTION ACROSS THE JOINT, WHICH LED TO WEAR OF THE TIBIAL INSERT. FRACTURE OF THE PATELLA WAS ALSO REPORTED BUT THE CAUSE, EXTENT, AND ORDER OF EVENTS CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. THE REVISED COMPONENT(S) WAS NOT RETURNED FOR EVALUATION AND NO RADIOGRAPHS WERE PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITANTS: (B)(6), 200-02-32 - ROTULA TRES TETONES 32MM. (B)(6), 244-03-03 - COMP. FEMORAL ASIMETRICO CEMENTADO HF PS Nº3 DRCH. (B)(6), 200-04-32 - BANDEJA TIB CEMENTADA ALETA 3F/2.T ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 11 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. APPROXIMATELY 5 YEARS AFTER THE INITIAL SURGERY, LYSIS IN THE TIBIAL IMPLANT WAS NOTED. APPROXIMATELY 9 YEARS AFTER INITIAL SURGERY, THE PATIENT EXPERIENCED PROGRESSIVE PAIN IN THEIR RIGHT KNEE. APPROXIMATELY 2 YEARS AFTER THE PAIN IN THEIR RIGHT KNEE, THE REVISION WAS PERFORMED. DELAMINATED POLYETHYLENE IN THE CENTRAL PIVOT AND BROKEN PATELLA POLY WAS INDICATED. THE PATIENT WAS REVISED WITH A COMPETITOR¿S DEVICES. NO PARTS OR PIECES FELL INTO PATIENT WOUND SITE AND THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE SURGEON DID NOT WANT TO PROVIDE THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2012, UTILIZING GPS, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 11 YEARS 4 MONTHS POST THE INITIAL PROCEDURE 2017, LYSIS IN THE TIBIAL IMPLANT WAS NOTED. IN 2021 THE PATIENT EXPERIENCED PROGRESSIVE PAIN IN THEIR RIGHT KNEE. THE REVISION WAS PERFORMED IN 2023. DELAMINATED POLYETHYLENE IN THE CENTRAL PIVOT AND BROKEN PATELLA POLY WAS INDICATED. THE PATIENT WAS REVISED WITH A COMPETITOR¿S DEVICES. NO PARTS OR PIECES FELL INTO PATIENT WOUND SITE AND THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE SURGEON DID NOT WANT TO PROVIDE THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116272 OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM SEE H10 JWH EXACTECH, INC. N/A UNK 10885862063991

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| H SEE H10.