BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, LEFT, 9X160MM

    MDR report key: 16101151 · Received January 5, 2023

    Report

    Report Number
    0009613350-2022-00682
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 5, 2022
    Report Date
    February 7, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505810
    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: BLUNT TIP SCREW, 4X42MM ITEM#: 47-2486-042-40, LOT#: 3078230. BLUNT TIP SCREW, 4X44MM ITEM#: 47-2486-044-40, LOT#: 3091268. BLUNT TIP SCREW, 4X46MM ITEM#: 47-2486-046-40, LOT#: 3076744. 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 - 00683, 0009613350 - 2022 - 00684, 0009613350 - 2023 - 00004.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS NO PRODUCTS WERE 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. TWO VIEWS OF THE LEFT SHOULDER DEMONSTRATE TRANSVERSE FRACTURE INVOLVING THE PROXIMAL HUMERAL DIAPHYSIS WITH INVOLVEMENT OF THE GREATER TUBEROSITY. INTRAMEDULLARY ROD WITH MULTIPLE SCREWS. POSSIBLE BACKING OUT OF THE PROXIMAL TO SCREWS. OVERALL FIT AND ALIGNMENT OF THE IMPLANT IS APPROPRIATE. MILD OSTEOPENIA. POSSIBLE BACKING OUT OF THE TWO PROXIMAL HUMERAL SCREWS. NO SURGICAL REPORT WAS PROVIDED. 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. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM OF THE 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 NAIL PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. THEREFORE, NO DESIGN CHANGES WERE CONDUCTED. 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 PATIENT UNDERWENT A REVISION SURGERY OF THE HIP DUE TO MIGRATION, APPROXIMATELY ONE (1) MONTH POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    900564 PROXIMAL HUMERUS, LEFT, 9X160MM ROD, FIXATION, INTRAMEDULLARY HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3082275 00889024505810

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention| H