BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT SZ11 STD COL

    MDR report key: 22532553 · Received July 17, 2025

    Report

    Report Number
    1818910-2025-12388
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MEH
    UDI-DI
    10603295478621
    PMA / PMN Number
    K213839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: BASIC QUESTION IS ¿WHAT IS IN THE BOX¿ AS THE PICTURE ON L971211 SHOWS A COLLARLESS STEM, WHEREAS IT SHOULD SHOW A COLLARED STEM AS PER THE L971214 EXAMPLE. I¿VE NOT ASKED FOR ANY OTHER CHECKS TO BE PERFORMED. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE OUTER PACKAGE LABEL INCORRECTLY DISPLAYED A COLLARLESS CORAIL STEM INSTEAD OF THE COLLARED STEM TO MATCH THE LABEL. THE OBSERVED CONDITION OF THE DEVICE HAS BEEN ADDRESSED THROUGH THE J&J MEDTECH ORTHOPEDIC QUALITY MANAGEMENT SYSTEM. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CORAIL AMT SZ11 STD COL WOULD HAVE CONTRIBUTED 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: NR WAS RAISED TO ADDRESS CURRENT COMPLAINT CONDITION. H11 ADDITIONAL NARRATIVE: CORRECTED: H3.

    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. H11 ADDITIONAL MANUFACTURER NARRATIVE: H3, H6: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THE OUTER PACKAGE LABEL INCORRECTLY DISPLAYED A COLLARLESS CORAIL STEM INSTEAD OF THE COLLARED STEM TO MATCH THE LABEL. THE OBSERVED CONDITION OF THE DEVICE HAS BEEN ADDRESSED THROUGH THE J&J MEDTECH ORTHOPEDIC QUALITY MANAGEMENT SYSTEM. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CORAIL AMT SZ11 STD COL WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT LABEL ISSUE WAS IDENTIFIED DURING THE INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: BASIC QUESTION IS ¿WHAT IS IN THE BOX¿ AS THE PICTURE ON L971211 SHOWS A COLLARLESS STEM, WHEREAS IT SHOULD SHOW A COLLARED STEM AS PER THE L971214 EXAMPLE. I¿VE NOT ASKED FOR ANY OTHER CHECKS TO BE PERFORMED. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (B)(4) EXTERNAL RE CORAIL COLLARED. THE PHOTO INVESTIGATION REVEALED THAT THE OUTER PACKAGE LABEL INCORRECTLY DISPLAYED A COLLARLESS CORAIL STEM INSTEAD OF THE COLLARED STEM TO MATCH THE LABEL. THE OBSERVED CONDITION OF THE DEVICE HAS BEEN ADDRESSED THROUGH THE J&J MEDTECH ORTHOPEDIC QUALITY MANAGEMENT SYSTEM. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CORAIL AMT SZ11 STD COL WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT LABEL ISSUE WAS IDENTIFIED DURING THE INVESTIGATION. 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: NR WAS RAISED TO ADDRESS CURRENT COMPLAINT CONDITION. H11 ADDITIONAL NARRATIVE: ADDED: D9.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PICTURE ON L971211 SHOWS A COLLARLESS STEM, WHEREAS IT SHOULD SHOW A COLLARED STEM AS PER THE L971214 EXAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711001 CORAIL AMT SZ11 STD COL CORAIL IMPLANTS : HIP FEMORAL STEM MEH DEPUY ORTHOPAEDICS INC US 4835580 10603295478621

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown