BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 19423422 · Received May 30, 2024

    Report

    Report Number
    1818910-2024-11807
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 30, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    UDI-DI
    10603295168782
    PMA / PMN Number
    K192946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 THAT 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. ADDED : D9 CORRECTED: D4 PRIMARY UDI NUMBER, 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 : ACCORDING TO THE INFORMATION RECEIVED, ¿FOLLOWING A VERIFICATION CHECK OF THE CORRECT STEM IMPLANT REQUIRED DURING A TOTAL HIP REPLACEMENT SURGERY, THE THEATRE NURSING TEAM REMOVED THE PLASTIC PACKAGING FROM A CORAIL NON COLLARED STEM IMPLANT BOX AND AFTER OPENING THE BOX, DISCOVERED THAT THE IMPLANT STICKERS ADHERED TO THE BOX INSIDE WERE FOR AN ACTIS HIGH OFFSET IMPLANT. THIS WAS DISCOVERED AT THE ROUTINE IMPLANT CHECK STAGE. THE IMPLANT WAS NOT OPENED, THE PACKAGING AND STICKERS WERE REMOVED FROM THE THEATRE AND A SECOND CORAIL NON COLLARED STEM OF THE SAME SIZE WAS OPENED. THIS CORAIL STEM HAD THE CORRECT STICKERS ADHERED TO THE BOX INSIDE AND WAS USED BY THE SURGEON.¿ THE PRODUCT AND PHOTOS ((B)(4) [EXTERNAL] 140524 MEDICAL PRODUCT COMPLAINT - SOUTHEAST LOCATION) WERE RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE PHOTOS WERE FORWARDED TO THE DEPUY CORK FOR MANUFACTURING INVESTIGATION. ON EXAMINATION OF THE RETURNED CORAIL2 STD SIZE 12, IT WAS FOUND THAT THE BATCH NUMBER LISTED ON THE PATIENT LABEL DID NOT MATCH THE PHYSICAL PRODUCT OR CARTON LABELS. BASED ON THE INVESTIGATION PERFORMED BY THE MANUFACTURED, THE REPORTED EVENT WAS RELATED TO MANUFACTURING ISSUE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CORAIL2 STD SIZE 12 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH ORTHOPAEDICS QUALITY SYSTEM. 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 WAS PERFORMED FOR THE FINISHED DEVICE [3L92512/ 4293164] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED DURING MANUFACTURING. HOWEVER, A CAPA-013569 AND (B)(4) HAVE BEEN RAISED TO ADDRESS CURRENT COMPLAINT CONDITION.

    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). 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

    FOLLOWING A VERIFICATION CHECK OF THE CORRECT STEM IMPLANT REQUIRED DURING A TOTAL HIP REPLACEMENT SURGERY, THE THEATRE NURSING TEAM REMOVED THE PLASTIC PACKAGING FROM A CORAIL NON COLLARED STEM IMPLANT BOX AND AFTER OPENING THE BOX, DISCOVERED THAT THE IMPLANT STICKERS ADHERED TO THE BOX INSIDE WERE FOR AN ACTIS HIGH OFFSET IMPLANT. THIS WAS DISCOVERED AT THE ROUTINE IMPLANT CHECK STAGE. THE IMPLANT WAS NOT OPENED, THE PACKAGING AND STICKERS WERE REMOVED FROM THE THEATRE AND A SECOND CORAIL NON COLLARED STEM OF THE SAME SIZE WAS OPENED. THIS CORAIL STEM HAD THE CORRECT STICKERS ADHERED TO THE BOX INSIDE AND WAS USED BY THE SURGEON.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? THERE WAS A VERY SHORT DELAY WHILE THE ISSUE WAS BEING DEBATED, NO MORE THAN A FEW MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099991 CORAIL2 STD SIZE 12 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM LZO DEPUY IRELAND - 9616671 4293164 10603295168782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown