BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 1, 9MM

    MDR report key: 18341353 · Received December 15, 2023

    Report

    Report Number
    1038671-2023-02998
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    December 6, 2023
    Report Date
    July 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 0993544 200-04-21 CEMENTED FINNED TIB. TRA SZ 2F/1T 0682132 234-02-01 OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 1, 1041384 200-02-32 THREE PEG PATELLA 32MM.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, PROSTHESIS FRACTURE, AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H3, H6. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND FRACTURE. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE FEMORAL LOOSENING; HOWEVER, THE REPORTED FEMORAL LOOSENING COULD NOT BE CONFIRMED. 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. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2007. THE SURGEON DID A FULL REVISION ON THE PATIENT ON (B)(6) 2023. THE PATIENT WAS SUFFERING WITH EFFUSION AND SHE LIMPED. THERE WAS FEMORAL LOOSENING. UNUSUAL AND IMPORTANT PE WEAR. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886481 PS TIBIAL INSERTS SZ 1, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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