BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, RIGHT, 11X160MM

    MDR report key: 10634688 · Received October 6, 2020

    Report

    Report Number
    0009613350-2020-00469
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    September 25, 2020
    Report Date
    June 22, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505797
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. ADDITIONAL: E1. CORRECTION: B4, G3, G6, H10. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: H2, H6 CORRECTION: B4, B5, D10 G3, G6, H10 D10, CONCOMITANT MEDICAL PRODUCTS: CORTICAL BONE SCREW, 4X30MM, REF:47248613040, LOT:3006025, CORTICAL BONE SCREW, 4X28MM, REF:47248612840, LOT:3010599, PROXIMAL HUMERUS NAIL CAP, 0MM, REF:47248801000, LOT:3008334. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM ON (B)(6) 2020. AFTER 1 WEEK, SURGEON NOTICED ONE OF THE IMPLANTED SCREW WAS BACKING OUT FROM THE PROPER POSITION. THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 AND THE BACKED OUT SCREW WAS REINSERTED. NO IMPLANTS WERE EXPLANTED. MOREOVER, IT WAS CONFIRMED THAT THE CORELOCK WAS TIGHTENED AFTER PLACING ALL THE INTERLOCKING SCREWS AND BY USING THE TORQUE SCREWDRIVER. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: ASSESSMENT OF IMAGING: SINGLE AP FILM OF THE RIGHT HUMERUS DEMONSTRATES AN INTRAMEDULLARY ROD WITH MULTIPLE PROXIMAL FIXATION SCREWS. ONE OF THE SCREWS DOES APPEAR TO HAVE BACKED OUT. FRACTURE INVOLVING THE GREATER TUBEROSITY. NO DISLOCATION. IMPRESSIONS: RIGHT HUMERAL INTRAMEDULLARY ROD WITH MULTIPLE FIXATION SCREWS, ONE OF WHICH APPEARS TO HAVE BACKED OUT. OVERALL FIT OF THE IMPLANTS IS APPROPRIATE. THE SECOND SUPERIOR MOST SCREW HAS BACKED OUT. OSTEOPENIA IS PRESENT. EVIDENCE OF AN AGE INDETERMINATE FRACTURE OF THE GREATER TUBEROSITY. RIGHT HUMERAL INTRAMEDULLARY ROD WITH MULTIPLE FIXATION SCREWS, ONE OF WHICH APPEARS TO HAVE BACKED OUT. A FIXATION SCREW HAS BACKED OUT, THE SECOND SUPERIOR MOST SCREW. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED FOR AN INVESTIGATION AS THEY REMAIN IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. CONCLUSION: IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM ON (B)(6) 2020. AFTER 1 WEEK, SURGEON NOTICED ONE OF THE IMPLANTED SCREW WAS BACKING OUT FROM THE PROPER POSITION. THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 AND THE BACKED OUT SCREW WAS REINSERTED. NO IMPLANTS WERE EXPLANTED. MOREOVER, IT WAS CONFIRMED THAT THE CORELOCK WAS TIGHTENED AFTER PLACING ALL THE INTERLOCKING SCREWS AND BY USING THE TORQUE SCREWDRIVER. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE EVALUATION OF THE RECEIVED X-RAYS, THE REPORTED EVENT CAN BE CONFIRMED. THERE WAS A BACKING OUT OF THE SECOND MOST SUPERIOR SCREW. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION (E.G. OTEOPENIA AND INFERIOR BONE QUALITY) AND BEHAVIOR, IMPLANTATION PROCEDURE OR DESIGN FEATURES. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE BACKING OUT OF THE SCREW REMAINS UNKNOWN. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. FURTHER INVESTIGATION HAS BEEN INITIATED IN ORDER TO DETERMINE THE NEED OF POTENTIAL CORRECTIVE AND / OR PREVENTIVE ACTIONS. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2020-00459, 0009613350-2020-00467, 0009613350-2020-00461, 0009613350-2020-00463.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 0

    NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED X-RAY FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH ANN NAIL SYSTEM ON AN UNKNOWN SIDE, A WEEK POST INITIAL SURGERY THE SURGEON NOTICED FROM THE X-RAY THAT ONE OF THE PROXIMAL SCREW HAD BACKED OUT, HENCE A REVISION SURGERY WAS PERFORMED DURING WHICH THE BACKED OUT SCREW WAS REINSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101908 PROXIMAL HUMERUS, RIGHT, 11X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3007826 00889024505797

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R SEE H10