BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, RIGHT, LONG, ÿ 10X260MM

    MDR report key: 19351136 · Received May 20, 2024

    Report

    Report Number
    0009613350-2024-00183
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 20, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024506039
    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. BLUNT TIP SCREW, ÿ 4X48MM ITEM# 47248604840 LOT# 3174924. BLUNT TIP SCREW, ÿ 4X48MM ITEM# 47248604840 LOT# 3181310. BLUNT TIP SCREW, ÿ 4X50MM ITEM# 47248605040 LOT# 3174978. BLUNT TIP SCREW, ÿ 4X52MM ITEM# 47248605240 LOT# 3174980. BLUNT TIP SCREW, ÿ 4X54MM ITEM# 47248605440 LOT# 3163116. CORTICAL BONE SCREW, ÿ 4X32MM ITEM# 47248613240 LOT# 3181926. CORTICAL BONE SCREW, ÿ 4X32MM ITEM# 47248613240 LOT# 3145997. PROXIMAL HUMERUS NAIL CAP, 0MM ITEM# 47248801000 LOT# 3189241. G2. REPORT SOURCE: 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 MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, D6, G3, G6, H2, H3, H6, H11. D6B. THIS DEVICE WAS NOT INDICATED TO HAVE BEEN REMOVED AND ACCORDING TO THE INFORMATION PROVIDED REMAINS IMPLANTED. 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 THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR REPORTED NAIL AND THE REPORTED PART AND LOT NAIL COMBINATION. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL. APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT COMPLAINED OF PAIN AND THE SURGEON FOUND #3 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. A REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860816 PROXIMAL HUMERUS, RIGHT, LONG, ÿ 10X260MM PROSTHESIS, TRAUMA HSB ZIMMER GMBH N/A 3175013 00889024506039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H