BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC POLY LINER MAX-ROM

    MDR report key: 7762228 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06698
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    June 14, 2013
    Report Date
    September 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1057 - CER BIOLOXD OPTION HD 36 MM ¿ 404080, 650-1065 - CER OPTION TYPE 1 TPR SLEVE -3 - 903420, THERAPY DATE: (B)(6) 2013. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-06692, 0001825034-2018-06702.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OP NOTES. REVISION OP NOTES SHOW THAT THE PATIENT EXPERIENCED SWELLING WITHOUT PAIN IN THE RIGHT HIP. ASPIRATION OF THE JOINT REVEALED ELEVATED INFLAMMATORY MARKERS AND CULTURE POSITIVE FOR PROPIONBACTERIUM. DURING I&D, FEMORAL STEM FOUND TO BE WELL INGROWN. ACETABULAR CUP WELL-FIXED AND OSTEOINTEGRATED. JOINT COPIOUSLY IRRIGATED. NEW POLY LINER AND HEAD/NECK IMPLANTED. HEMOVAC DRAIN WAS PLACED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT OF MODULAR COMPONENTS APPROXIMATELY 1 YEAR POST PRIMARY RIGHT TOTAL HIP ARTHROPLASTY DUE TO PROPIONIBACTERIUM INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604000 E1 RINGLOC POLY LINER MAX-ROM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 474950

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R