BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD -3MM

    MDR report key: 7826045 · Received August 29, 2018

    Report

    Report Number
    0001825034-2018-08535
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    December 12, 2017
    Report Date
    August 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: ITEM# 16-116056 RNGLC+ LTD HOLE SHELL SZ56 LOT# 853290; ITEM# XL-105894 ARCOMXL RLC 10DEG 36MM SZ24 LOT# 804240; ITEM# 11-103207 TAPERLOC POR FMRL LAT 13.5X147 LOT# 280750. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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 THAT PATIENT UNDERWENT TOTAL HP ARTHROPLASTY APPROXIMATELY 3 YEARS AGO. PATIENT UNDERWENT REVISION 2 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED IONS, HETEROTOPIC OSSIFICATION, AND METALLOSIS. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671688 36MM COCR MOD HD -3MM PROSTHESIS HIP LZO ZIMMER BIOMET, INC. N/A 605140

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R