BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL HEAD

    MDR report key: 8320971 · Received February 8, 2019

    Report

    Report Number
    0001822565-2019-00557
    Event Type
    Injury
    Date Received
    February 8, 2019
    Report Date
    March 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE ONE PATIENT WAS REVISED FOR SYMPTOMATIC ADVERSE LOCAL TISSUE REACTION AND ELEVATED ION LEVELS. BLACK METAL DEBRIS WAS NOTED AT FEMORAL COMPONENT TRUNNION NECK TAPER AND ON THE FEMORAL HEAD INDICATING CORROSION. PATIENT REQUIRED DEBRIDEMENT OF NECROTIC PERIARTICULAR SOFT TISSUE, MUSCLE, AND BONE SECONDARY TO ALTR FROM HEAD- NECK TAPER CORROSION. HEAD WAS REVISED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNK ITEM, UNKNOWN FEMORAL STEM, UNK LOT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, LOCATION OF PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. KWON, Y., ROSSI, D., MACAULIFFE, J., PENG, Y., & ARAUZ, P. (2018). RISK FACTORS ASSOCIATED WITH EARLY COMPLICATIONS OF REVISION SURGERY FOR HEAD-NECK TAPER CORROSION IN METAL-ON-POLYETHYLENE TOTAL HIP ARTHROPLASTY. THE JOURNAL OF ARTHROPLASTY, 33(10), 3231-3237. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001822565-2019-00558.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ONE PATIENT WAS REVISED FOR SYMPTOMATIC ADVERSE LOCAL TISSUE REACTION AND ELEVATED ION LEVELS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114805 UNKNOWN FEMORAL HEAD PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R