BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC TIB INSERT SIZE 4, 9MM

    MDR report key: 17754530 · Received September 15, 2023

    Report

    Report Number
    1038671-2023-02275
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 4, 2022
    Report Date
    December 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862266101
    PMA / PMN Number
    K150890
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10. CONCOMITANTS: SN#(B)(6); CAT# 02-010-06-0240 - TRU CC FEMORAL SIZE 4 LEFT. SN#(B)(6); CAT# 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM. SN#(B)(6); CAT# 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM. SN#(B)(6)8; CAT# 02-010-06-0542 - TRU POST. AUG. SIZE 4, 10MM. SN#(B)(6); CAT# 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T. SN#(B)(6); CAT# 02-012-50-3014 - TRU TIB AUG 1/2 RL SZ 3, 10MM. SN#(B)(6); CAT# 02-012-60-1480 - TRU STEM EXT 14MM X 80MM. SN#(B)(6); CAT# 02-012-60-1612 - TRU STEM EXT 16MM X 120MM. SN#(B)(6); CAT# 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM. SN#(B)(6); CAT# 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM. SN#(B)(6); CAT# 208-10-15 - CC FEMORAL AUG SCREW 15MM. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. NO OTHER INFORMATION IS AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, PATELLAR LOOSENING, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 AND THEN APPROXIMATELY 6 YEARS 9 MONTHS LATER THE PATIENT HAD A REVISION SURGERY. REVISION OPERATIVE REPORT OF (B)(6) 2022 -PATIENT WAS REVISED TO COMPETITOR'S DEVICES. POSTOPERATIVE DIAGNOSIS: LEFT KNEE-FAILED CONSTRAINED TOTAL KNEE, ASEPTIC LOOSENING FEMORAL COMPONENT, AND OSTEOLYSIS. PATIENT HAD PRESENTED WITH PAINFUL UNSTABLE CONSTRAINED LEFT KNEE. PROCEDURE: THERE WAS EXTENSIVE SYNOVITIS AND A THOROUGH SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED AND WAS NOTED TO HAVE WEAR AND DELAMINATION. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND WAS REMOVED, THERE WAS MARKED FEMORAL OSTEOLYSIS. THERE WAS NO EVIDENCE OF INFECTION. THE TIBIAL COMPONENT WAS REMOVED WITH MARKED OSTEOLYSIS PROXIMALLY. THE PATELLA COMPONENT WAS WELL FIXED, BUT THERE WAS SOME WEAR WITH DELAMINATION, IT WAS REMOVED. THERE WAS SOME PATELLAR OSTEOLYSIS, WHICH WAS DEBRIDED. DRESSINGS WERE APPLIED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS TO BE DISCHARGED HOME WHEN COMFORTABLE AND MET ALL PHYSICAL THERAPY GOALS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268574 LOGIC CC TIB INSERT SIZE 4, 9MM SEE H10 JWH EXACTECH, INC. 10885862266101

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H SEE H10.