BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 16714382 · Received April 11, 2023

    Report

    Report Number
    1038671-2023-00642
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    September 14, 2022
    Report Date
    January 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. EXPIRATION DATE AND MANUFACTURED DATES CANNOT BE DETERMINED. PMA 510K CANNOT BE DETERMINED / DEVICE IS UNKNOWN. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF FEMORAL LOOSENING 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.

    Description of Event or Problem · 0

    LEGAL CASE - (B)(6). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT IS VERIFIED BILATERAL KNEES ON (B)(6) 2015. THE 68 YEAR OLD FEMALE HAD LEFT KNEE REVISION (B)(6) 2022, APPROXIMATELY 6 YEARS AND 11 MONTHS AFTER THEIR INITIAL REPLACEMENT SURGERY. POSTOP DIAGNOSIS: MECHANICAL LOOSENING OF INTERNAL LEFT KNEE PROSTHETIC JOINT. THE FEMORAL COMPONENT WAS EXPOSED AND FOUND TO BE GROSSLY LOOSE. THE FEMORAL COMPONENT WAS REMOVED WITHOUT DIFFICULTY. AN UNDEFINED MEDICAL DEFECT WAS NOTED DISTALLY AND POSTERIORLY. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO RECOVERY UNIT. 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. SERIAL #: (B)(4), CATEGORY #: 02-012-44-2009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 9MM; SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. PMA-510K: K110547. CONCOMITANTS: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624179 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 9MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention UNKNOWN.