BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS RP INSRT SZ10 6MM

    MDR report key: 9497792 · Received December 19, 2019

    Report

    Report Number
    1818910-2019-124180
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    May 3, 2018
    Report Date
    December 3, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295053132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: 7872108. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: 16 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WERE NO DEVIATIONS ASSOCIATED WITH THIS LOT. THERE WAS ONE NC ASSOCIATED WITH THIS LOT: NR-0099319. 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. INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL "ATTORNEY". (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, REVISED TO ADDRESS LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, AND PAIN. THE SURGEON REPORTED A LOT OF ADHESION TISSUE AROUND THE PATELLA AND PATELLAR TENDON. HE INDICATED THE KNEE WAS VERY STIFFNESS. THERE WAS NO ADHERENCE AT THE FEMORAL - CEMENT TO IMPLANT INTERFACE. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS COMPLETELY LOOSE AT THE COMPONENT TO CEMENT INTERFACE. HE NOTED THE PATELLA WAS FOUND TO BE PLACED LATERAL AND WITH SOME WEAR, AND REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015 (TIBIAL TRAY, CEMENT, PATELLA AND FEMORAL COMPONENT); DOI: (B)(6) 2016 (TIBIAL INSERT); DOR: (B)(6) 2018 (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292967 ATTUNE PS RP INSRT SZ10 6MM ATTUNE IMPLANT : KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671 1516-51-006 7872108 10603295053132

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention