BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS MODULAR REVISION SYSTEM CONE PROXIMAL BODY STANDARD OFFSE

    MDR report key: 7752648 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05639
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    March 7, 2018
    Report Date
    October 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ITEM # 650-1058, HEAD, LOT # UNK; ITEM # 11-300919, DISTAL TAPER, LOT # 945120; ITEM # UNK, HIP-UNKNOWN-CUPS-UNK, LOT # UNK; ITEM # UNK, HIP-UNKNOWN-LINERS-UNK, LOT # UNK; ITEM # 650-1065, TAPER SLEEVE, LOT # UNK. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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. AN ADDITIONAL REPORT HAS BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE REPORT 0001825034-2018-09674.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-300919 ¿ ARCOS MODULAR REVISION HIP SYSTEM 945120; UNKNOWN ¿ UNKNOWN SHELL ¿ UNKNOWN; UNKNOWN ¿ UNKNOWN E1 MAX LINER ¿ UNKNOWN; UNKNOWN ¿ UNKNONW BIOLOX DELTA CERAMIC HEAD - UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -05647; 0001825034 -2018 -05643; 0001825034 -2018 -05645; 0001825034 -2018 -05646.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT ASPIRATION OF THE LEFT HIP APPROXIMATELY 6 YEARS POST LEFT HIP REVISION SURGERY FOR UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595814 ARCOS MODULAR REVISION SYSTEM CONE PROXIMAL BODY STANDARD OFFSE PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 156040

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other