BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 2.5

    MDR report key: 17216018 · Received June 28, 2023

    Report

    Report Number
    1038671-2023-01486
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 8, 2023
    Report Date
    January 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001221
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. PENDING INVESTIGATION. H11. CORRECTED DATA -H7 & H9 - THE FEMORAL COMPONENT IS NOT A RECALLED DEVICE.

    Additional Manufacturer Narrative · 0

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANTS: 02-012-35-2509 - LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM- RECALL DEVICE. 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T. 200-02-32 - THREE PEG PATELLA 32MM 3944817. 200-02-32 - THREE PEG PATELLA 32MM 3944847. 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. 204-70-00 - TIBIAL STEM EXT. SCREW. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE FEMORAL LOOSENING AND INSTABILITY AND INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED FEMORAL LOOSENING AND INSTABILITY COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    UPDATE -REVISION OPERATIVE REPORT OF (B)(6) 2023 POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF RIGHT FEMORAL COMPONENT/PREMATURE WEAR OF RIGHT POLY LINER. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO EVIDENCE OF GROSS PURULENCE OR TISSUE NECROSIS, VISUAL INSPECTION REVEALED SEVERE SYNOVITIC CHANGES CONSISTENT WITH POLYETHENE WEAR DISEASE. THE FEMORAL COMPONENT WAS GROSSLY LOOSE. PATELLAR COMPONENT- WELL-FIXED WITHOUT EVIDENCE OF MACROSCOPIC WEAR. POLY DEMONSTRATED ADVANCED ASYMMETRIC WEAR INVOLVING PRIMARILY THE MEDIAL PORTION OF THE COMPONENT WITH EXTENSIVE PITTING AND DELAMINATION. THE TIBIAL COMPONENT DEMONSTRATED MILD OSTEOLYSIS SURROUNDING THE OUTER MARGINS OF THE IMPLANT; IT WAS FOUND TO BE WELL FIXED. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TRANSFERRED TO HER HOSPITAL BED AND TAKEN TO RECOVERY IN STABLE CONDITION. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 64 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 8 YEARS POST THE INITIAL PROCEDURE DUE TO INSTABILITY AND OSTEOLYSIS. THE POLY AND FEMUR WERE REVISED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED DUE TO THE RECALL. X-RAYS AND PHOTO IMAGES WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158343 LOGIC FEMORAL PS CEM RIGHT SZ 2.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2.5 UNK 10885862001221

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention SEE H10