BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 26MM RINGLOC LINER HIGHWALL 23

    MDR report key: 7550423 · Received May 29, 2018

    Report

    Report Number
    0001825034-2018-03570
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 2, 2018
    Report Date
    October 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK970501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO UNKNOWN PRODUCT LOCATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: BIOMET 26MM DIA COCR MOD HD -6MM NK, ITEM#: 163620, LOT#: 437050, BIOMET M/H RADIAL SOLID/APX SHL 52MM, ITEM#: 13-104052, LOT#: 523550, ITEM # UNKNOWN, UNKNOWN STEM LOT # UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03569.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 16 YEARS POST-IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392560 ARCOM 26MM RINGLOC LINER HIGHWALL 23 HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 385280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R