BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LOCKING PLATE

    MDR report key: 6800336 · Received August 17, 2017

    Report

    Report Number
    0001825034-2017-06454
    Event Type
    Injury
    Date Received
    August 17, 2017
    Report Date
    November 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: - UNKNOWN SCREW: P/N UNKNOWN L/N UNKNOWN. REFERENCE: JAMES W. GALLENTINE, JAMES K. DEORIO, MATTHEW J. DEORIO. (2007). BUNION SURGERY USING LOCKING-PLATE FIXATION OF PROXIMAL METATARSAL CHEVRON OSTEOTOMIES. FOOT & ANKLE INTERNATIONAL/VOL. 28, NO. 3/MARCH 2007. HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/17371660. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AND PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE ROOT CAUSE WAS DETERMINED TO BE THE OPERATIONAL CONTEXT CONTRIBUTING TO THE EVENT. AS PER THE JOURNAL "WE SUSPECT HIS LACK OF CORRECTION WAS SECONDARY TO INADEQUATE RELEASE OF THE SESAMOIDS AND INADEQUATE DISPLACEMENT OF THE METATARSAL HEAD LATERALLY BECAUSE HIS IMA ONLY DECREASED FROM 17.2 TO 13.9 DEGREES." 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.

    Description of Event or Problem · 1

    IT IS REPORTED IN THE JOURNAL ARTICLE THAT HAND INNOVATIONS LOCKING PLATE (HAND INNOVATIONS, MIAMI, FLORIDA) WAS USED IN 14 FEET AND (B)(4) BOW PLATE (B)(4)) WAS USED FOR SIX FEET; CLINICAL AND RADIOGRAPHIC RESULTS WERE EVALUATED. ALTHOUGH THE AUTHORS REPORTED GOOD CLINICAL OUTCOMES AND PERHAPS SUPERIOR PRODUCT PERFORMANCE, ONE FAILED CORRECTION WAS REPORTED. THE FAILED CORRECTION WAS PROCEDURE RELATED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580745 UNKNOWN LOCKING PLATE PLATE, FIXATION HRS BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R