BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD SIZE 40MM

    MDR report key: 8306577 · Received February 5, 2019

    Report

    Report Number
    0001825034-2019-00441
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    May 30, 2018
    Report Date
    February 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN LINER, UNKNOWN CUP, UNKNOWN - TAPERLOC STEM SIZE 13.5MM STD OFFSET - UNKNOWN. 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. DOI:10.1016/J.ARTH.2018.05.046. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS 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 - 2019 - 00442.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE PATIENT UNDERWENT A HIP REVISION DUE TO ADVERSE LOCAL TISSUE REACTION AND ELEVATED COCR LEVELS. THE ARTICLE STATES THAT BLACK METAL DEBRIS AT THE FEMORAL COMPONENT TRUNNION NECK TAPER AND ON THE BORE OF THE FEMORAL HEAD WAS FOUND, GROSSLY INDICATING CORROSION OF THE HEAD-NECK TAPER JUNCTION. ADDITIONALLY, THE ARTICLE STATES THAT EACH PATIENT REQUIRED DEBRIDEMENT OF VARYING DEGREES OF NECROTIC PERIARTICULAR SOFT TISSUE, MUSCLE, AND BONE SECONDARY TO ALTR FROM HEAD-NECK TAPER CORROSION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101510 COCR HEAD SIZE 40MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R