BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLPE REV LINER CONST 54X3

    MDR report key: 7602679 · Received June 14, 2018

    Report

    Report Number
    0001822565-2018-01277
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    January 11, 2016
    Report Date
    June 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 00-7000-054-20, TM REVISION SHELL 54MM, 62473283, 22-301310, ARCOS CON SZ A HI 50MM HA, 455410, 22-300817, ARCOS 17X150MM SPL TPR DIST HA, 001110, 163669, 32MM MOD HEAD COCR STD NECK, 00J2915341, 00662406520, BONE SCREW SELF-TAPPING 20 MM LENGTH 6.5 MM DIA., 62161132, 00662406550, BONE SCREW SELF-TAPPING 50 MM LENGTH 6.5 MM DIA., 61906700. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. X-RAYS WERE REVIEWED. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. NORMAL BONE MINERALIZATION. NO SIGNS OF LOOSENING OR RADIOLUCENCY. OF NOTE, THERE ARE MULTIPLE METALLIC LOOSE BODIES WITHIN THE INFERIOR ASPECT OF THE JOINT SPACE WITH SURROUNDING OSSIFICATION, PRESUMABLY EVIDENCE OF METALLOSIS ALTHOUGH INFECTION CANNOT BE EXCLUDED. TAKING INTO ACCOUNT THE PATIENTS HISTORY OF INFECTION, THIS IS MOST LIKELY WHAT IS DEPICTED IN THE PRE-OP X-RAYS, ALTHOUGH THIS IS UNCONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. H3 OTHER TEXT : PRODUCT LOCATION UNKNOWN

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL PATIENT UNDERWENT A LEFT HIP REVISION SURGERY BECAUSE OF STAGE TWO INFECTION. SUBSEQUENTLY, PATIENT REPORTED SEVERE HIP PAIN AND EXTREME DIFFICULTY PERFORMING DAILY ACTIVITIES AT ONE-YEAR FOLLOW UP VISIT. PATIENT ALSO REPORTED SEVERE HIP PAIN, DIFFICULTY WALKING AND BEING UNABLE TO PERFORM USUAL ACTIVITIES AT THREE-YEAR FOLLOW UP VISIT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443802 XLPE REV LINER CONST 54X3 PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 62197940

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other