BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 15MM

    MDR report key: 13423978 · Received February 2, 2022

    Report

    Report Number
    1038671-2022-00138
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    January 14, 2021
    Report Date
    January 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 02-012-35-3015/2024607/LOGIC TIBIA PS MOD INSRT SZ 3 15MM/510K K033883. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND PRE-REVISION X-RAYS WERE NOT PROVIDED. H7: Z-0019-2022.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICE: 02-012-35-3015/2024607/LOGIC TIBIA PS MOD INSRT SZ 3 15MM/510K K033883. H3: THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, CRACKING AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, DEPENDING ON WHICH OF THE TWO IDENTIFIED TIBIAL INSERTS WAS IMPLANTED, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. 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. D4 & G4: UPDATED TO 9999/UNK (SEE ACTIVITY). H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS AND 1 MONTH POST RIGHT SIDE TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO POLYETHYLENE WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY 4.3 YEARS POST INITIAL RIGHT TKA, THE MALE PATIENT PRESENTED WITH PAIN AND SWELLING FOLLOWING TOTAL KNEE ARTHROPLASTY. THE PATIENT HAS HAD SIGNIFICANT SYMPTOMS IN THIS RIGHT KNEE FOR YEARS, BUT THEY CONTINUE TO WORSEN. IMAGING SHOWS SIGNIFICANT OSTEOLYSIS IN BOTH HIS FEMUR AND TIBIA WITH WELL FIXED IMPLANTS. HE ALSO HAS A LARGE EFFUSION. ASPIRATION OF THE KNEE JOINT ON MULTIPLE OCCASIONS HAS SHOWN NO SIGN OF INFECTION. PATIENT HAD A RIGHT KNEE REVISION WHERE POLYETHYLENE LINER WAS REMOVED. THERE WAS A SMALL CRACK IN THE POST OF THE POLYETHYLENE LINER BUT NO FRACTURE FRAGMENTS. THERE WAS SOME VISIBLE PITTING IN THE POLYETHYLENE. THERE WAS MILD OSTEOLYSIS OF THE MEDIAL AND LATERAL FEMORAL CONDYLES, HOWEVER THE CONDYLES AND EPICONDYLES WERE INTACT. THERE WAS A LARGE AMOUNT OF OSTEOLYSIS IN THE TIBIAL PLATEAU WITH AN AREA OF OSTEOLYSIS THAT HAD BROKEN THROUGH THE ANTEROMEDIAL CORTEX AS WELL AS AN AREA OF OSTEOLYSIS THAT HAD BROKEN THROUGH POSTERIORLY. PATIENT REVISED TO COMPETITOR¿S DEVICES. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259445 LOGIC TIBIA PS MOD INSRT SZ 3 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 9999 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10.| SEE H11.