BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 15277030 · Received August 23, 2022

    Report

    Report Number
    1038671-2022-00951
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    December 8, 2016
    Report Date
    April 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173638
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (DEVICE EVALUATED BY MFR) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; NO REASON FOR REVISION WAS GIVEN.

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 3583654, 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4. 3577520, 02-012-44-4009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM. 3548589, 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. 3583165, 200-02-35 - THREE PEG PATELLA 35MM. 2792176, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 2974139, 201-78-81 - 3" TROCAR, MOD. HEX 2PK. 3555903, 201-78-81 - 3" TROCAR, MOD. HEX 2PK. 130648, 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS BONE MARROW 60ML. 126893, SA-3615 - CANNULA STYLE APP TIP. H3. INVESTIGATION RESULTS-UPDATED: THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF LOOSENING AND TIBIAL INSERT WEAR. THE ASEPTIC (NON-INFECTED) LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL AND TIBIAL COMPONENTS AND THE BONE. THE TIBIAL INSERT WEAR MAY HAVE BEEN DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, THIRD BODY WEAR, PATIENT RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, PROSTHESIS WEAR WAS NOT REPORTED IN THE REVISION OPERATIVE REPORT. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. H11. CORRECTED DATA ¿ H6 MEDICAL DEVICE PROBLEM CODE NO FRACTURE OF DEVICE NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT SUSTAINED INJURIES RESULTING FROM A KNEE PROSTHESIS IMPLANTED AT THE TIME OF HIS LEFT KNEE PROCEDURE PERFORMED ON OR ABOUT (B)(6) 2014, AND REVISED ON OR ABOUT 2016.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION - THE PATIENT BEGAN EXPERIENCING INCREASED PAIN ABOUT 2 YEARS POSTOPERATIVELY. BONE SCANS SUGGESTED LOOSENING AND THERE WERE NO SIGNS OF INFECTIONS. PER THE REVISION OPERATIVE REPORT, THERE WAS A ¿LITTLE BIT OF OVERGROWTH OF SOFT TISSUE OVER THE PATELLA, BUT OTHERWISE IN GOOD CONDITION¿THERE WERE NO SIGNS OF INFECTION. THE BONE WAS EXTREMELY SOFT ON THE LATERAL ASPECT WHERE HE WAS 17 AND AFTER FURTHER INVESTIGATION FOUND THAT THERE WAS SOME LOOSENING ON THIS FEMORAL IMPLANT.¿ THE PATIENT¿S POSTOPERATIVE DIAGNOSIS WAS ¿LOOSENING OF TIBIAL AND FEMORAL COMPONENTS DUE TO OSTEOPENIC BONE.¿ WEAR WAS NOT REPORTED FOR THE TIBIAL INSERT IN THE OPERATIVE REPORT. PATIENT TOLERATED THE PROCEDURE WELL WITH NO PROBLEM OR COMPLICATION, TRANSFERRED TO RECOVERY ROOM INSTABLE AND SATISFACTORY CONDITION. THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352728 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862173638

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention