BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PS FB INSRT SZ 6 5MM

    MDR report key: 16214320 · Received January 20, 2023

    Report

    Report Number
    1818910-2023-01612
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    January 9, 2023
    Report Date
    January 20, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295050063
    PMA / PMN Number
    K111433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED TIBIAL INSERT FOUND EVIDENCE OF DEFORMATION/WITNESS MARKS ALONG THE POSTERIOR GROOVES THAT ARE DESIGNED TO SLIDE INTO THE LOCKING FEATURE OF THE MATING TIBIAL TRAY. THE OBSERVED DAMAGE IS CONSISTENT WITH UNSUCCESSFUL INSERTION ATTEMPTS DURING THE PROCEDURE. THE MATING TIBIAL TRAY WAS NOT RETURNED, THEREFORE, A FUNCTIONAL TEST WAS NOT ABLE TO BE PERFORMED. HOWEVER, DUE TO THE VISUAL DAMAGE OBSERVED, THE DIFFICULTY/INABILITY TO ASSEMBLE MATING DEVICES CAN BE CONFIRMED. ADDITIONALLY, HANDLING DAMAGE CAN BE OBSERVED FROM THE ANTERIOR AND BOTTOM ASPECT OF THE DEVICE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WERE PERFORMED FOR THE FINISHED DEVICE DHR 151640605/ D22062619, IT WAS MANUFACTURED ON 29-JUN-2022. 30 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION, AND NO NON-CONFORMANCES WERE IDENTIFIED. 1) QUANTITY MANUFACTURED: (B)(4) PARTS. 2) DATE OF MANUFACTURE: 29-JUN-2022 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO. 4) EXPIRY DATE: 31-MAY-2027 5) IFU REFERENCE: MSA0902-00-859 DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WERE PERFORMED FOR THE FINISHED DEVICE DHR 151640605/ D22062619, IT WAS MANUFACTURED ON 29-JUN-2022. 30 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION, AND NO NON-CONFORMANCES WERE IDENTIFIED. 1) QUANTITY MANUFACTURED: (B)(4) PARTS 2) DATE OF MANUFACTURE: 29-JUN-2022 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO. 4) EXPIRY DATE: 31-MAY-2027. 5) IFU REFERENCE: MSA0902-00-859 H3.

    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 · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSERT WOULD NOT LOCK INTO THE TIBIA PROPERLY. AFTER ATTEMPTING MULTIPLE TIMES TO HAVE IT SEAT DOWN, USING THE FB INSERT IMPACTOR, A NEW INSERT NEEDED TO BE OPENED. THERE IS NOW DAMAGE TO THE LOCKING MECHANISM. THERE WAS A SURGICAL DELAY OF 2 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405317 ATTUNE PS FB INSRT SZ 6 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671 1516-40-605 D22062619 10603295050063

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female