BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COMPONENT

    MDR report key: 7762057 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06744
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    April 11, 2011
    Report Date
    September 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    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: EP-105933 ¿ RINGLOC ACETABULAR LINER ¿ 777480. THERAPY DATE: (B)(6) 2011. 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: 0001825034-2018-06750.

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT - MEDICAL PRODUCT: CATALOG #: 11-104050, M/H SLD/APX HLE RNGLC SHL 50MM, LOT # 799370. CATALOG #: 15-103202, TAPERLOC MICROP LAT FMRL 7.5MM, LOT # 365230. REPORTED EVENT IS CONSIDERED CONFIRMED PER OPERATIVE NOTES WHICH STATED THE PATIENT HAD AN INFECTION AND PURULENT HEMATOMA. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT PRESENTED WITH PERSISTENT DRAINAGE AND ERYTHEMA APPROXIMATELY 1 MONTH POST TOTAL HIP ARTHROPLASTY. PATIENT UNDERWENT IRRIGATION, DEBRIDEMENT AND REVISION DUE TO INFECTION. THE LINER AND HEAD COMPONENTS WERE REMOVED AND REPLACED. 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
    603754 MODULAR HEAD COMPONENT PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 557290

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R