BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PS FB INSRT SZ 7 7MM

    MDR report key: 17765521 · Received September 18, 2023

    Report

    Report Number
    1818910-2023-18981
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 29, 2023
    Report Date
    September 18, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295050223
    PMA / PMN Number
    K111433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # :(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DHR REVIEW: A MANUFACTURING RECORD EVALUATION WERE PERFORMED FOR THE FINISHED DEVICE DHR 151640707/ D22113863, IT WAS MANUFACTURED ON 23-NOV-2022. 27 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT : DHR REVIEW: A MANUFACTURING RECORD EVALUATION WERE PERFORMED FOR THE FINISHED DEVICE DHR 151640707/ D22113863, IT WAS MANUFACTURED ON 23-NOV-2022. 27 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY - IT WAS REPORTED THAT THE POLY INSERT WOULD NOT SEAT CORRECTLY ON TRAY. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS REVEALED DEFORMATION/WITNESS MARKS ALONG ONE OF THE POSTERIOR GROOVES THAT IS 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. THE ATTUNE KNEE SYSTEM SURGICAL TECHNIQUE (DSUS/JRC/0316/1437 REV. K) ADVISES ON PAGES 79-80, ¿FOR FIXED BEARING TIBIAL COMPONENTS, ANGLE THE TIBIAL INSERT POSTERIORLY AND SLIDE THE POSTERIOR TABS INTO THE POSTERIOR UNDERCUTS OF THE TIBIAL BASE. THE FIXED BEARING TIBIAL INSERT IS IMPACTED INTO PLACE ON THE TIBIAL BASE, USING THE FIXED BEARING INSERT IMPACTOR. POSITION AN IMPACTOR AT APPROXIMATELY 60 DEGREES ON THE INSERT SO THAT THE NOTCH RESTS ON THE ANTERIOR EDGE OF THE CENTER OF THE INSERT. USE A MALLET TO STRIKE THE FIXED BEARING INSERT IMPACTOR.¿ FOLLOWING THESE STEPS WILL SUCCESSFULLY LOCKING THE INSERT INTO THE BASE AS INTENDED. THE OBSERVED DAMAGED CONDITION SUGGESTS THE POSTERIOR GROOVES ON THE UNDERSIDE OF THE TIBIAL INSERT WERE NOT PROPERLY ALIGNED WITH THE UNDERCUT LOCKING FEATURES OF THE TIBIAL BASE. THIS WOULD CONTRIBUTE TO THE DIFFICULTY/INABILITY TO MATE THE INSERT WITH THE TIBIAL COMPONENT FOLLOWING MULTIPLE INSERTION ATTEMPTS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE PS FB INSRT WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USER ERROR, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT - DHR REVIEW: A MANUFACTURING RECORD EVALUATION WERE PERFORMED FOR THE FINISHED DEVICE DHR 151640707/ D22113863, IT WAS MANUFACTURED ON (B)(6) 2022. 27 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION, AND NO NON-CONFORMANCES WERE IDENTIFIED. CORRECTED: H3.

    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 POLY INSERT WOULD NOT SEAT CORRECTLY ON TRAY. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040274 ATTUNE PS FB INSRT SZ 7 7MM ATTUNE IMPLANT : KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671 D22113863 10603295050223

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female