BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS FEM LT SZ 6 CEM

    MDR report key: 10087492 · Received May 26, 2020

    Report

    Report Number
    1818910-2020-12505
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    September 21, 2018
    Report Date
    May 12, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295041634
    PMA / PMN Number
    K111433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDED CONCOMITANT PRODUCTS. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT: 12 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. NO PARTS WERE SCRAPPED FROM LOT: 8326020. 2 NCS (NON-CONFORMANCES) FOUND ASSOCIATED WITH LOT: 8326020. NR-0142098 IS ASSOCIATED WITH LOT: 8326020. THIS WAS OPENED IN RELATION TO CTQ (CRITICAL TO QUALITY) ISSUE. ALL AFFECTED PARTS WERE RELEASED FROM HOLD AS THERE WAS NO RISK TO THE PRODUCT THEREFORE THERE IS NO CORRELATION BETWEEN NR-0142098 AND THE COMPLAINT FAILURE MODE NR-0100007 IS ASSOCIATED WITH LOT: 8326020. THIS WAS OPENED IN RELATION TO THE DRAWING REVISION NUMBER ON THE COMPLETED INSPECTION SHEET THAT DID NOT MATCH THE DRAWING REVISION ON THE LOT TRAVELLER. DURING FURTHER INVESTIGATION IS WAS FOUND THAT A CLERICAL CHANGE HAS BEEN MADE BETWEEN THE REVISIONS OF THE DOCUMENT, THEREFORE THERE IS NO CORRELATION BETWEEN NR-0100007 AND THE COMPLAINT FAILURE MODE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). OCCUPATION: LAWYER. (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

    PATIENT RECEIVED LEFT PRIMARY ATTUNE TKA TO TREAT PAIN AND LIMITED MOBILITY DUE TO AVASCULAR NECROSIS (AVN). THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON NOTES THAT THE PATIENT¿S POOR BONE QUALITY DUE TO AVASCULAR NECROSIS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, SWELLING, POOR ROM, AND INSTABILITY SECONDARY TO FEMORAL AVN PROGRESSION. THE PATIENT HAD A PREVIOUS ARTHROSCOPIC EXCISION OF SCAR TISSUE, BUT THE PAIN PERSISTED. UPON ENTERING THE JOINT, THE SURGEON ENCOUNTERED AND DEBRIDED SCAR TISSUE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED DUE TO PROGRESSION OF THE PATIENT¿S PREEXISTING AVN. THERE WAS QUESTIONABLE LOOSENING OF THE TIBIAL TRAY AT AN UNKNOWN INTERFACE, SO IT WAS REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATELLA WAS RETAINED. THE PATIENT COMPETITOR REVISION PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2018, LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550400 ATTUNE PS FEM LT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL JWH DEPUY IRELAND - 9616671 1504-10-106 8326020 10603295041634

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS RP INSRT SZ6 5MM| ATTUNE RP TIB BASE SZ 6 CEM| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO