BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE PATELLA

    MDR report key: 8741090 · Received June 27, 2019

    Report

    Report Number
    1818910-2019-97035
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    April 18, 2019
    Report Date
    April 18, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). N THE RECEIVED DEVICE WAS FORWARDED TO COMMERCIALIZED PRODUCT DEVELOPMENT FOR EVALUATION. REVIEW OF THE RECEIVED DEVICE CONFIRMED THE REPORTED EVENT. THE INVESTIGATION FOUND NO EVIDENCE OF PRODUCT MALFUNCTION OR PRODUCT ERROR AND THE NEED FOR CORRECTIVE ACTION WAS NOT ESTABLISHED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DID THE EVENT HAPPEN DURING A PROCEDURE? YES . WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? PATIENT HAD ATTUNE KNEE APPROX 3 YEARS AGO BY (B)(6). PATIENT HAS COMPLAINED OF KNEE PAIN AND AS A RESULT WAS SCOPED BY MR. (B)(6) PRIOR TO TODAY¿S CASE WITH TISSUE SAMPLES TAKEN. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE EXTENDED GREATER THAN 30 MINUTES DUE TO THE FAILURE? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? YES. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: SAMPLES TAKEN DID HIGHLIGHT AN INFECTION. PROCEDURE CARRIED OUT TODAY WAS TO PERFORM POLY EXCHANGE AND WASH OUT, HOWEVER AFTER FURTHER INVESTIGATION MR. (B)(6) DECIDED TO REMOVE THE CONSTRUCT AND TREAT THE PATIENT WITH AN ANTIBIOTIC SPACER. THE IMPLANTS HAVE BEEN RETAINED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532151 UNKNOWN KNEE PATELLA KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention