BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD +3MM

    MDR report key: 7207435 · Received January 19, 2018

    Report

    Report Number
    0001825034-2018-00353
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 20, 2017
    Report Date
    February 22, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ARCOMXL 36MM RLC LNR HW SZ25 CAT: XL-105915 LOT: 845650, ARCOS CON SZ A HI 50MM CAT: 11-301310 LOT: 269880, PLATT LT TRIFLANGE SZ 25 CAT: PM0000936 LOT: 644080, TI LOCK-SCR CANCLS6.5X50MM CAT: CP161947 LOT: 387380, TI LOCK-SCR CANCLS6.5X40MM CAT: CP161945 LOT: 035430, TI LOCK-SCR CANCLS6.5X35MM CAT: CP161944 LOT: 962000, ARCOS 16X150MM SPL TPR DIST CAT: 11-300816 LOT: 256740, TI LOCK-SCR CANCLS6.5X40MM CAT: CP161945 LOT: 683530, TI LOCK-SCR CANCLS6.5X40MM CAT: CP161945 LOT: 962020, TI LOCK-SCR CANCLS6.5X25MM CAT: CP161942 LOT: 154490, TI LOCK-SCR CANCLS6.5X30MM CAT: CP161943 LOT: 035390. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2018 - 00352, 0001825034 - 2018 - 00353, 0001825034 - 2018 - 00354. CONCOMITANT PRODUCT(S): XL-105915 ARCOMXL 36MM RLC LNR HW SZ25 LOT 845650. A 11-363663 36MM COCR MOD HD +3MM LOT 013170. A 11-301310 ARCOS CON SZ A HI 50MM LOT 269880. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT HIP REVISION AND IRRIGATION AND DEBRIDEMENT DUE TO INFECTION. DURING THE PROCEDURE, THE HEAD, LINER, AND CONE BODY WERE REVISED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50023 36MM COCR MOD HD +3MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 013170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R