BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTEGRADE FEM CONNECTING BOLT

    MDR report key: 7023387 · Received November 11, 2017

    Report

    Report Number
    0001825034-2017-09975
    Event Type
    Malfunction
    Date Received
    November 11, 2017
    Date of Event
    October 3, 2017
    Report Date
    July 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT CODE 185050 CORRESPONDS TO THE COMPONENT ITEM #14-442093-00. THIS LOT WAS ISSUED TO TWO FINISHED GOOD LOTS OF ITEM #14-442093: 370490 AND 354450.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE FEMORAL ANTEGRADE CONNECTING BOLD THREAD FRACTURE SHOWED THAT IT FRACTURED DUE TO OVERLOAD, AS INDICATED BY SHEARED DUCTILE DIMPLES ON THE FRACTURE SURFACE. BASED ON THE DIRECTION OF THE SHEARED DIMPLES, THE CRACK WAS SUSPECTED TO HAVE INITIATED ON THE OUTSIDE EDGE OF THE THREAD AND PROPOGATED TOWARDS THE INNER EDGE BEFORE THE FRACTURE. EDS SEMI-QUANTITATIVE ELEMENTAL ANALYSIS AND HARDNESS ANALYSIS OF THE BOLT FRACTURE SHOWED THAT IT WAS IN CONFORMANCE WITH SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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. THE REPORTED DEVICE IS USED FOR TREATMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN. THE EVENT OCCURRED IN (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS: 14-443334, FEM NAIL TROCH LT 10.5MMX340MM, 103680, 14-444181, OFFSET END CAP 12X5MM, 975850, 14-444185, OFFSET END CAP 12X1MM, 953150, 14-406090, 6X90MM CANN PART THD RECON SCR, 843940, 14-406095, 6X95MM CANN PART THD RECON SCR, 915370, 14-405040, TI-DBLE LEAD CORT 5.0X40MM SCR, 096940, 14-405040, TI-DBLE LEAD CORT 5.0X40MM SCR, 114680, 14-405042, TI-DBLE LEAD CORT 5.0X42MM SCR, 095920, 14-443434, FEM NAIL TROCH RT 10.5MMX340MM, 327430.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. MANUFACTURING DATE - LOT :# 370490 - NOV 12, 2009, LOT :# 354450 - NOV 3, 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CONNECTING BOLT FRACTURED UPON INSERTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802585 ANTEGRADE FEM CONNECTING BOLT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1