BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS FEM LT SZ 5 NAR CEM

    MDR report key: 10237703 · Received July 6, 2020

    Report

    Report Number
    1818910-2020-15086
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    March 16, 2020
    Report Date
    June 24, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295041702
    PMA / PMN Number
    K111433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 PRODUCT CODE 150410125, WORK ORDER (B)(4) WAS MANUFACTURED ON 04/APR/14. 12 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WAS ONE NON CONFORMANCE ASSOCIATED WITH THIS LOT: NR-0142098. THIS NR WAS OPENED BECAUSE PVE-116342-GRRR GAUGE R&R REPORT FOR ATTUNE PS FEMORAL COMPONENTS CAM RADIUS SWEEP GAUGE INSPECTION METHOD DID NOT REFERENCE CTQ 27 AS OUTLINED IN RELEVANT CTQ LIST. HOWEVER, THIS HAS NO CORRELATION TO THE FAILURE MODE AS IT IS AN ISSUE IDENTIFIED WITH THE REPORT ASSOCIATED WITH THE GAUGE. ALL PRODUCT ASSOCIATED WITH THIS NR WAS DISPOSITION UNDER PD-0130868 AS IT WAS CONCLUDED THERE WAS NO PRODUCT RISK. H10 ADDITIONAL NARRATIVE: ADDED: H6 (PATIENT CODES) . H6 PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE DEVICE REVISION OR REPLACEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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 A RIGHT PRIMARY ATTUNE TO TREAT PAIN SECONDARY TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE SURGEON NOTES THE SURGERY REQUIRED ADDITIONAL ASSISTANCE DUE TO THE PATIENT¿S SEVERE OBESITY WITH A BMI GREATER THAN 40. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN AND INSTABILITY SECONDARY TO LOOSENING AND VARUS MIGRATION OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED SYNOVITIS AND SCAR TISSUE. THE TIBIAL TRAY WAS SUBSIDED AND WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS A CORTICAL BONE DEFECT OF THE TIBIA. THE FEMORAL COMPONENT WAS WELL-BUT REVISED. THE SURGEON NOTES THERE WAS SLIGHT LOOSENING OF THE FEMORAL COMPONENT SECONDARY TO EXTENSIVE OSTEOLYSIS. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT WAS REVISED WITH DEPUY REVISION PRODUCTS UTILIZING COMPETITOR CEMENT. THE SURGEON NOTES THE SURGERY REQUIRED ADDITIONAL ASSISTANCE DUE TO THE PATIENT¿S SEVERE OBESITY WITH A BMI GREATER THAN 40. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2020. LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695321 ATTUNE PS FEM LT SZ 5 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL JWH DEPUY IRELAND - 9616671 1504-10-125 7882720 10603295041702

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention ATTUNE MEDIAL ANAT PAT 32MM| ATTUNE PS FEM LT SZ 5 NAR CEM| ATTUNE PS RP INSRT SZ 5 8MM| ATTUNE RP TIB BASE SZ 4 CEM| SMARTSET GMV 40G US EO| SMARTSET MV 40G - EO