BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6959 · Received September 8, 1993

    Report

    Report Number
    6959
    Event Type
    Injury
    Date Received
    September 8, 1993
    Date of Event
    July 20, 1993
    Report Date
    September 7, 1993
    Manufacturer
    TOTAL KNEE PROSTHESIS
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SEE PREVIOUSLY SUBMITTED REPORT #220038-1993-0002. PT HAD TKR IN 11/91 AT ANOTHER FACILITY. DEVELOPED SEPTIC JOINT IN 1992. WAS TREATED WITH ANTIBIOTICS BOTH AS OUTPT AND INPT DURING 92-93. ADMITTED 7/20/93 TO HOSP FOR REMOVAL OF TKR. PT WAS INTERVIEWED AND HAS NO MEMORY OF RECEIVING DOCUMENTATION OF DEVICE MFR. THEREFORE, MFR UNKNOWN. DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA, INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN Implant UNKNOWN JWH TOTAL KNEE PROSTHESIS 5220-0469MM 75345800

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other