BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, RIGHT, 11X160MM

    MDR report key: 16633512 · Received March 29, 2023

    Report

    Report Number
    0009613350-2023-00128
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    February 17, 2023
    Report Date
    May 10, 2023
    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). REPORT SOURCE: FOREIGN: JAPAN. CONCOMITANT MEDICAL PRODUCTS: ANN BLUNT TIP SCREW 4X44MM; ITEM# 47248604440, LOT# 3024705; ANN BLUNT TIP SCREW 4X48MM; ITEM# 47248604840, LOT# 3010667; ANN BLUNT TIP SCREW 4X52MM; ITEM# 47248605240, LOT# 3054541. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2023 - 00129, 0009613350 - 2023 - 00130, AND 0009613350 - 2023 - 00131. 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: B4, B5, G3, G6, H1, H2, H3, H6, H10. 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. DEVICES ARE USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. TWO VIEWS OF THE RIGHT SHOULDER DEMONSTRATE AN INTRAMEDULLARY ROD WITH FOUR PROXIMAL AND TWO DISTAL SCREWS. THREE OF THE PROXIMAL SCREWS APPEAR TO HAVE BACKED OUT FROM THEIR ORIGINAL POSITION. HOWEVER, NO OTHER RADIOGRAPHS WERE PROVIDED TO COMPARE THE POSITION OF THE SCREWS AT AN EARLIER TIME POINT. NO FRACTURE SEEN. MILD RADIOLUCENCY SURROUNDS THE INTRAMEDULLARY ROD. MODERATE GLENOHUMERAL DEGENERATIVE CHANGE. NO BONY FRACTURE. POSSIBLE EARLY LOOSENING OF THE INTRAMEDULLARY ROD AS A RESULT. NO IDENTIFIABLE CONTRIBUTING FACTORS THAT COULD HAVE CAUSED THE SCREWS TO MOVE FROM THEIR INTENDED POSITION. BASED ON THE INVESTIGATION, IT CAN BE ASSUMED THAT THE MIGRATION OF THE SCREWS MIGHT BE MULTI FACTORIAL, 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 LOCKING 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. 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 NINE DAYS AFTER INITIAL RIGHT HUMERAL NAIL IMPLANTATION THREE OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THEIR PROPER POSITION. NO INTERVENTION IS PLANNED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1714667 PROXIMAL HUMERUS, RIGHT, 11X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3064824 00889024505797

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other SEE H10 NARRATIVE