BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS HA MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM

    MDR report key: 6601126 · Received May 31, 2017

    Report

    Report Number
    0001825034-2017-03477
    Event Type
    Injury
    Date Received
    May 31, 2017
    Date of Event
    November 23, 2015
    Report Date
    January 25, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY/TYPE I TAPER P/N 22-301301 L/N 725630. MODULAR HEAD COCR P/N 164440 L/N 00J3315968. ACETABULAR SHELL REGENEREX POROUS TITANIUM CONSTRUCT P/N PT-124858 L/N 642120. ADVANTAGE LINER P/N P0860044 L/N 0000900990. (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K090757. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03474, 0001825034-2017-03477, 0001825034-2017-03478, 0001825034-2017-03479.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AND SHOULD NOT HAVE BEEN REPORTED. THE INITIAL REPORT SHOULD BE VOIDED AS IT WAS SUBMITTED IN ERROR. THIS EVENT HAS BEEN REPORTED IN 3006946279-2017-00143.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT IRRIGATION, DEBRIDEMENT AND ANTIBIOTIC TREATMENT ONE MONTH POST-IMPLANTATION DUE TO WOUND DEHISCENCE. NO PRODUCTS WERE REPORTED TO HAVE BEEN REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383504 ARCOS HA MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 296080

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention