BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 3, 11MM

    MDR report key: 16378276 · Received February 15, 2023

    Report

    Report Number
    1038671-2023-00169
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    March 16, 2022
    Report Date
    November 28, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048318
    PMA / PMN Number
    K032606
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. PLEASE NOTE THE CONCOMITANTS LISTED ARE FOR THE LEFT AND THE RIGHT KNEE. IT WAS NOT POSSIBLE TO DETERMINE WHICH PRODUCTS HAVE BEEN IMPLANTED SPECIFICALLY IN THE LEFT OR RIGHT KNEE BASED ON THE INFORMATION RECEIVED FOR THIS PATIENT. CONCOMITANT MEDICAL PRODUCT: CONCOMITANTS: 200-03-35 - ONE PEG PATELLA 35MM, LOT #: 0999305; 200-03-35 - ONE PEG PATELLA 35MM. LOT #:1055246; 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T, LOT #:1070663; 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T, LOT #:1131262; 234-02-03 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3, LOT #:1092784; 234-03-03 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3, LOT #:1123069; 204-23-11 - PS TIBIAL INSERTS SZ 3, 11MM, LOT #: 0882761. ***SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 204-23-11 - PS TIBIAL INSERTS SZ 3, 11MM, LOT #: 1098144. ***SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND INSUFFICIENT BONDS BETWEEN THE KNEE COMPONENTS AND THE BONES, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECT CODES TO REFLECT INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL INFORMATION- D1, D4 SERIAL NUMBER, EXP DATE, D8, H4.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, B6

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL BILATERAL KNEE REPLACEMENT SURGERY ON (B)(6) 2008 AND WAS IMPLANTED WITH A OPTETRAK DEVICE. SPECIFICALLY, PLAINTIFF WAS IMPLANTED WITH A OPTETRAK POSTERIOR STABILIZED TIBIAL INSERT, ALONG WITH AN OPTETRAK STEM, OPTETRAK PATELLA, OPTETRAK SCREWS, A OPTETRAK TIBIAL TRAY, AND A OPTETRAK POSTERIOR STABILIZED FEMORAL COMPONENT. FOLLOWING THE SURGERY, PLAINTIFF BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. PLAINTIFF UNDERWENT A LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 14 YEARS 2 MONTHS POST INITIAL PROCEDURE. PLAINTIFF CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT ON A DAILY BASIS IN BOTH OF HER KNEES WHICH LIMITS HER DAILY ACTIVITIES AND QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED BY THE LEGAL DEPARTMENT ON 19 FEB 2023: OPERATIVE REPORT AND REVISION OPERATIVE REPORT [RELEVANT INFORMATION] PREOPERATIVE DIAGNOSIS FOR BILATERAL TOTAL KNEE ARTHROPLASTY- BILATERAL KNEE DEGENERATIVE JOINT DISEASE. DOB: (B)(6) 1939. FEMALE. THE PATIENT WAS SENT TO PACU IN STABLE CONDITION. LEFT KNEE REVISION- THE KNEE WAS EXAMINED UNDER ANESTHESIA AND FOUND TO HAVE POLY WEAR AND LOOSE COMPONENTS WITH DECREASED BONE INTEGRITY. AN EXTENSIVE SYNOVECTOMY WAS PERFORMED, THERE WAS OBVIOUS WEAR AND OXIDATION OF THE POLY. THE BONE QUALITY WAS POOR. THE PATELLA WAS FOUND TO BE STABLE AND NOT OXIDIZED; THEREFORE, LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126744 PS TIBIAL INSERTS SZ 3, 11MM SEE H10 JWH EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 11MM UNK 10885862048318

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention SEE H10.