BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21403801 · Received February 18, 2025

    Report

    Report Number
    1038671-2025-01017
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    July 5, 2017
    Report Date
    June 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    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 ADDITIONAL AND/OR CORRECTED INFORMATION. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF INFECTION AND PROSTHESIS WEAR 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.

    Additional Manufacturer Narrative · 0

    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. D10 CONCOMITANTS: 02-012-44-3011 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM, (B)(6), 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3, (B)(6), 02-012-42-3008 - LOGIC PTS, SIZE 3, 8MM, (B)(6), 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T, (B)(6), 200-02-35 - THREE PEG PATELLA 35MM, (B)(6), (B)(6) - GPS KNEE IMPLANT KIT, 05 0310 13 020.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL BRIEF, ON (B)(6) 2013, PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA). EVENTUALLY, PATIENT BEGAN TO SUFFER FROM INCREASING PAIN, SWELLING, AND INSTABILITY IN HER LEFT KNEE, WHICH SUBSEQUENTLY BECAME INFECTED. ON (B)(6) 2017, PATIENT UNDERWENT REVISION OF HER LEFT OPTETRAK DEVICE. UPON EXPLANATION OF THE OPTETRAK DEVICE, PATIENT¿S SURGEON OBSERVED THAT THERE WERE SIGNS OF METAL-WEAR DEBRIS, AS WELL AS EVIDENCE OF MICROMOTION BETWEEN THE METAL AUGMENT AND THE TIBIAL TRAY. THE OPERATIVE SURGEON STATED HIS BELIEF THAT ¿THIS WAS THE CAUSE¿ OF THE INFECTION THAT NECESSITATED REVISION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539658 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| H SEE H10.