BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, HIP

    MDR report key: 9995702 · Received April 24, 2020

    Report

    Report Number
    0002648920-2013-01077
    Event Type
    Injury
    Date Received
    April 24, 2020
    Report Date
    April 22, 2020
    Product Code
    LPH
    PMA / PMN Number
    K002960
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED LINER SHOWS DAMAGE DURING THE REMOVAL PROCESS. THE HEAD IDENTIFIED DARK DEBRIS AND THREAD LIKE PATTERN ON THE TAPER SURFACE. NO OTHER DAMAGED NOTED. SEM ANALYSIS REVEALED DEPOSITS ON THE TAPER SURFACE AND CIRCUMFERENTIAL GROOVES, POSSIBLY FROM CONTACT WITH THE SURFACE TEXTURE OF THE STEMS TAPER. AXIAL MARKS OR CORROSION MARKS, PITTING AND ETCHING WERE OBSERVED ON THE TAPER¿S SURFACE. QUANTITATIVE EDS OF THE TAPER¿S SURFACE IDENTIFIED BIOLOGICAL MATERIAL CONTAINING SOME OR ALL OF C, O, P, S, CL, K, AND CA. COCRMO SUBSTRATE MATERIAL SHOWING ELEVATED LEVELS OF CR, M, AND O POSSIBLE EVIDENCE OF CORROSION PRODUCTS AND TITANIUM, POSSIBLY TRANSFERRED FROM THE STEMS TAPER. EDS ANALYSIS OF THE POLISHED BEARING SURFACE OF THE HEAD WAS CONSISTENT WITH COCRMO ALLOY. ADDITIONAL INFORMATION DOES NOT CHANGE THE CONCLUSION OF THE PREVIOUS INVESTIGATION. 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461644 PROSTHESIS, HIP LPH

    Patients

    Seq Age Sex Outcome Treatment
    1