BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN, PROXIMAL HUMERUS, RIGHT, 11X160MM

    MDR report key: 15014006 · Received July 14, 2022

    Report

    Report Number
    0009613350-2022-00369
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    June 16, 2022
    Report Date
    September 5, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505797
    PMA / PMN Number
    K181827
    Removal / Correction Number
    N/A
    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). CONCOMITANT MEDICAL PRODUCTS: CORTICAL BONE SCREW, 4X26MM; CATALOG#: 47248612640; LOT#: 3091271. CORTICAL BONE SCREW, 4X28MM; CATALOG#: 47248612840; LOT#: 3082043. PROXIMAL HUMERUS NAIL CAP, 0MM; CATALOG#: 47248801000; LOT#: 3082050. TORQUE LIMITING HANDLE; CATALOG#: 27923; LOT#: UNKNOWN. REPORT SOURCE: 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 MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2022-00370, 0009613350-2022-00371, 0009613350-2022-00372, 0009613350-2022-00373.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H6, H10. AS NO PRODUCT WAS RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. NO SURGICAL REPORT OR X-RAYS ARE AVAILABLE FOR INVESTIGATION. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT FURTHER POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. THE INVESTIGATION ALSO CONSIDERED WHETHER THE DESIGN LIMITATION OF THE CORELOCK MECHANISM COULD BE A POTENTIAL CONTRIBUTING FACTOR. HOWEVER, FURTHER BIOMECHANICAL TESTING IDENTIFIED THAT THE PRODUCT PERFORMANCE IS IN AN ACCEPTABLE 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 THE SURGEON FOUND THAT THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION 1 MONTH AFTER THE INITIAL SURGERY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT'S CONDITION. REVISION SURGERY IS NOT CURRENTLY PLANNED. NO FURTHER PATIENT OUTCOME WAS PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426263 ANN, PROXIMAL HUMERUS, RIGHT, 11X160MM ROD, FIXATION, INTRAMEDULLARY HSB ZIMMER SWITZERLAND MANUFACTURING GMBH 47-2496-160-11 3064824 00889024505797

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other