BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM

    MDR report key: 19475393 · Received June 6, 2024

    Report

    Report Number
    0009613350-2024-00214
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505780
    PMA / PMN Number
    K200814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: (B)(6) ¿ ANN BLUNT TIP SCREW 4X36MM- 3137767; (B)(6) ¿ ANN BLUNT TIP SCREW 4X36MM -3158944; (B)(6) ¿ ANN BLUNT TIP SCREW 4X44MM - 3137792; (B)(6) ¿ ANN BLUNT TIP SCREW 4X58MM - 3091310; (B)(6) -ANN CORT BONE SCREW 4 X 28MM-3147835; (B)(6) -ANN CORT BONE SCREW 4 X 28MM-3149090; (B)(6) -ANN WASHER SMALL-3137819; (B)(6) -AFFIXUS PH NL CAP 0MM-3162162. G2: FOREIGN: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PRODUCTS AND ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. IT CAN BE ASSUMED THAT MULTIPLE CONTRIBUTING FACTORS, RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR OR IMPLANTATION PROCEDURE, CONTRIBUTED TO THE MIGRATION OF THE SCREWS. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM OF THE AFFIXUS NAIL AS A POTENTIAL CONTRIBUTING FACTOR. AS PART OF THE DEEPER INVESTIGATION, A SCIENTIFIC LITERATURE SEARCH WAS CONDUCTED AND A SYSTEMATIC REVIEW OF THE OUTCOME OF INTRAMEDULLARY NAILING FOR ACUTE PROXIMAL HUMERUS FRACTURE SHOWED THAT SCREW MIGRATION AND PERFORATION INTO THE JOINT IS THE SECOND MOST COMMON COMPLICATION FOLLOWING SECONDARY LOSS OF REDUCTION. IN ADDITION, SCIENTIFIC LITERATURE OF COMPETITOR AND PREDICATE DEVICES WERE ASSESSED. THIS REVIEW HAS SHOWN THAT THE AFFIXUS® NATURAL NAIL® PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY NINE (9) MONTHS AFTER INITIAL IMPLANTATION DUE TO A PROXIMAL SCREW THAT WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9474 PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM AFFIXUS TRAUMA IMPLANT HSB ZIMMER GMBH N/A 3161353 00889024505780

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE