BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 6

    MDR report key: 19947963 · Received August 9, 2024

    Report

    Report Number
    1038671-2024-02754
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 7, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862001276
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES 5032910 02-010-01-0360 - LOGIC FEMORAL PS CEM RIGHT SZ 6. 4205671 02-012-41-6050 - LOGIC TIBIA TRAPTRAY CEM SZ 6F/5T. 5484338 200-02-38 - THREE PEG PATELLA 38MM. 3609305 201-78-12 - HOLDING PIN LG HEAD SHARP POINT MED 2PK. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. 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

    **08-AUG-2024 ADDITIONAL SUMMARY** IT IS REPORTED VIA LEGAL DOCUMENTATION THAT PATIENT UNDERWENT RK REVISION (B)(6) 2024.(OP REPORT ATTACHED). CLINICAL HISTORY: PATIENT PRESENTS WITH FAILED RIGHT TOTAL KNEE REPLACEMENT IN THE SETTING OF RECALLED IMPLANT, WITH OSTEOLYSIS OF THE DISTAL FEMUR AND HE PROXIMAL TIBIA. PRE/POSTOPERATIVE DIAGNOSIS: STATUS POST RIGHT TOTAL KNEE REPLACEMENT; DISTAL FEMUR AND PROXIMAL TIBIA OSTEOLYSIS. PROCEDURE: REVISION TOTAL KNEE REPLACEMENT FEMORAL AND TIBIAL COMPONENTS OPERATIVE NOTES: KNEE JOINT EXPOSED. PATELLA WAS DISLOCATED LATERALLY AND FOUND TO BE STABLE. INSERT WAS REMOVED. FEMORAL COMPONENT WAS FOUND TO BE LOOSE. BONY INVENTORY AFTER REMOVAL OF THE FEMORAL COMPONENT REVEALED AORI TYPE 2B BONE LOSS. TIBIAL COMPONENT WAS THEN REMOVED, DURING THIS TIME A SMALL DEFECT WAS NOTED IN THE POSTERIOR CORTEX OF THE PROXIMAL TIBIA, WHICH WAS LATER FILLED WITH CERAMENT. BONY INVENTORY AFTER REMOVAL CEMENT OF THE TIBIA REVEALED AORI TYPE 1 BONE LOSS. TRIAL COMPONENTS WERE SIZED, THEN REMOVED. CERAMENT WAS USED TO FILL THE DEFECT IN THE POSTERIOR TIBIAL CORTEX. BONY SURFACES WERE THEN IRRIGATED AND DRIED. IMPLANTS WERE IMPACTED. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE SERIAL NUMBER 4455716 IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-44-6011 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 11MM. SERIAL: (B)(6). 510K: K110547. UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: NO. CONCOMITANT DEVICES: 5032910 02-010-01-0360 - LOGIC FEMORAL PS CEM RIGHT SZ 6. 4205671 02-012-41-6050 - LOGIC TIBIA TRAPTRAY CEM SZ 6F/5T. 5484338 200-02-38 - THREE PEG PATELLA 38MM. 3609305 201-78-12 - HOLDING PIN LG HEAD SHARP POINT MED 2PK. **ORIGINAL SUMMARY** IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 71 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS, NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE, REVISION SURGERY; PAIN FOLLOWING SURGERY AND DURING THE REHABILITATION PERIOD, PHYSICAL THERAPY; LIMITED ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674377 LOGIC FEMORAL PS CEM RIGHT SZ 6 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862001276

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R SEE H11.