BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEADS

    MDR report key: 9215466 · Received October 21, 2019

    Report

    Report Number
    0002648920-2019-00758
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    December 3, 2018
    Report Date
    October 21, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:0106010003 LOT NUMBER:4023402 BRAND NAME: AVENIR MULLER STEM, CATALOG NUMBER:00620005622 LOT NUMBER:62653713 BRAND NAME: SHELL POROUS WITH CLUSTER, CATALOG NUMBER:00625006535 LOT NUMBER:62754329 BRAND NAME: BONE SCREW, CATALOG NUMBER:00630505636 LOT NUMBER:62718393 BRAND NAME: XLPE LINERS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2019-00757. A LINER AND HEAD WERE RETURNED FOR EVALUATION. VISUAL REVIEW OF THE HEAD SHOWS DISCOLORATION AND DARK DEBRIS IN THE TAPER AND ON THE FLAT SURFACE. VISUAL REVIEW OF THE LINER SHOWS FRACTURES. GOUGING, SCRATCHES, CRACKS, AND DEFORMITIES TO THE LINER ARE NOTED IN SEVERAL LOCATIONS. THE HEAD WAS SUBMITTED FOR FURTHER ANALYSIS. THE ANALYSIS DETERMINED DEPOSITS ON THE TAPER SURFACE AND CIRCUMFERENTIAL GROOVES, POSSIBLY FROM THE IMPRINTING OF THE SURFACE TEXTURE OF THE 12/14 STEM TAPER. AXIAL WEAR OR CORROSION MARKS AND LIGHT SURFACE PITTING WERE ALSO VISIBLE ON THE TAPER SURFACE. QUANTITATIVE EDS ANALYSIS OF THE TAPER SURFACE SHOWED COMBINATIONS OF BIOLOGICAL MATERIAL CONTAINING SOME OR ALL OF THE ELEMENTS C, N, O, P, S, CL AND CA. COCRMO SUBSTRATE MATERIAL THAT SHOWED ELEVATED LEVELS OF CR, MO AND O IN THE DARKER-IMAGING DEPOSIT AREAS, POSSIBLY EVIDENCE OF CORROSION PRODUCTS. TITANIUM, POSSIBLY TRANSFER FROM THE STEM TAPER. EDS ANALYSIS OF THE POLISHED BEARING SURFACE OF THE HEAD WAS CONSISTENT WITH COCRMO ALLOY. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN & ELEVATED METAL ION LEVELS APPROXIMATELY 3 MONTHS POST IMPLANTATION. CORROSION WAS NOTED DURING THE REVISION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010014 COCR HEADS PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 62715667

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R