BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 5

    MDR report key: 20824216 · Received December 2, 2024

    Report

    Report Number
    1038671-2024-04585
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    December 5, 2022
    Report Date
    March 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001269
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. 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

    D10: CONCOMITANTS: 2996509 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5 1736296 02-012-35-5013 - LOGIC TIBIA PS MOD INSRT SZ 5 13MM 2951048 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T 3585943 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T 3563142 200-02-41 - THREE PEG PATELLA 41MM 3606553 200-02-41 - THREE PEG PATELLA 41MM 1765968 02-012-35-5015 - LOGIC TIBIA PS MOD INSRT SZ 5 15MM THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2014. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 8 YEARS 5 MONTHS POST PRIMARY PROCEDURE. ON (B)(6) 2022 OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED BILATERAL TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING AND POLYETHYLENE WEAR. THE RIGHT PATELLA WAS FOUND TO BE WELL FIXED. THE FEMORAL COMPONENT WAS EASILY DISIMPACTED FROM THE INTACT CEMENT MANTLE. TIBIA WAS CHECKED AND WAS FOUND TO BE WELL FIXED. THERE WAS A LARGE CYST POSTERIOR LATERAL, WHICH WAS NOT DECOMPRESSED FROM THE ARTHROTOMY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    RELATED (B)(4) LK REV RELATED (B)(4) R QUAD DEHISCENCE ******* ORIGINAL SUMMARY I WOULD LIKE TO RECEIVE MORE INFORMATION ON THE COMPENSATION BEING OFFERED OTHER THAN THE TIME MISSED FROM WORK PAYMENTS. I HAVE DOUBLE KNEE REPLACEMENTS SCHEDULED ON (B)(6) AND I WOULD LIKE TO MAKE SOME DECISIONS ON ALL OPTIONS AVAILABLE ASAP. INITIAL SURGERY: (B)(6) 2014 REFER TO CASE-(B)(4). 19 JUL 2023 / A CYBURT - ADDITIONAL INFORMATION; LEGAL SHORT, REVISION OP REPORT, RIGHT QUAD OP REPORT RECEIVED VIA LEGAL ON 28-JUN-2023 AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2014. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 8 YEARS 5 MONTHS POST PRIMARY PROCEDURE. 05 DEC 2022 OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED BILATERAL TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING AND POLYETHYLENE WEAR. THE RIGHT PATELLA WAS FOUND TO BE WELL FIXED. THE FEMORAL COMPONENT WAS EASILY DISIMPACTED FROM THE INTACT CEMENT MANTLE. TIBIA WAS CHECKED AND WAS FOUND TO BE WELL FIXED. THERE WAS A LARGE CYST POSTERIOR LATERAL, WHICH WAS NOT DECOMPRESSED FROM THE ARTHROTOMY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. UPDATED INFO RECEIVED 09/05/2023 ADDITIONAL INFORMATION DOES NOT ALTER THE REPORTABILITY ASSESSMENTS OR FAILURE MODE. NEW INFORMATION DOES NOT NEED FU MDR AT THIS TIME, WAIT FOR ENG INVESTIGATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97218 LOGIC FEMORAL PS CEM RIGHT SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 5 10885862001269

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H SEE H11