BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 8 CEM

    MDR report key: 9249416 · Received October 29, 2019

    Report

    Report Number
    1818910-2019-112747
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    October 2, 2019
    Report Date
    October 2, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042426
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> THE RECEIVED DEVICE WAS FORWARDED TO COMMERCIALIZED PRODUCT DEVELOPMENT FOR EVALUATION. REVIEW OF THE RECEIVED DEVICE CONFIRMS THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    (B)(6) HOSPITAL TRAUMATOLOGIST, PERFORMS ATTUNE KNEE PROSTHESIS REVIEW SURGERY TO THE GMG PATIENT, BECAUSE THE PATIENT HAD BEEN SUFFERING PAIN IN HIS LEFT KNEE FOR MONTHS, OPERATED WITH A PRIMARY PROSTHESIS ON (B)(6) 2016 IN THE SAME HOSPITAL. AT THE TIME OF THE REVISION SURGERY THE DOCTOR MAKES AN INCISION WHERE HE TAKES CULTURES, AND IT IS FOUND THAT THE PROBLEM IS PRESENTED BY THE PRIMARY TIBIAL PLATEAU THAT IS LOOSENED, WHICH LEAVES COMPLETELY WITHOUT CEMENT ATTACHED TO THE IMPLANT, THE AREA OF THE TIBIAL PLATEAU IS THE BONE WITH ALL THE INTER-DIGITED CEMENT MAKING ITS EXTRACTION DIFFICULT AND THE FEMORAL COMPONENT WAS COMPLETELY ADHERED TO THE BONE WITHOUT PROBLEMS. IN ADDITION, THE DOCTOR REQUESTS TO SEND THE POLYETHYLENE INSERT FOR STUDY. CURRENT PATIENT STATUS: HE IS HOSPITALIZED POST-OPERATED ATTUNE REVISION PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044907 ATTUNE FB TIB BASE SZ 8 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 8316730 10603295042426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ATTUNE PS FB INSRT SZ 8 8MM| ATTUNE PS FEM RT SZ 5 NAR CEM