BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 32MM RLOC LNR 10D/HWL 23

    MDR report key: 7148346 · Received December 27, 2017

    Report

    Report Number
    0001825034-2017-11157
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    December 4, 2017
    Report Date
    February 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR# 0001825034-2018-00855. CONCOMITANT MEDICAL PRODUCTS: MODULAR HEAD COMPONENT 32MM, PN163667, LN899590, MLRY-HD POR FMRL 11X160MM, PN11-104111, LN953130. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS OF THE EXPLANTS, THAT SHOW THE LINER CRACKED AND BROKEN, BLACK DEBRIS NOTED ON COCR HEAD & POLY LINER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED THIRTEEN YEARS POST IMPLANTATION DUE TO LINER WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928717 ARCOM 32MM RLOC LNR 10D/HWL 23 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 216780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R