BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B STD 80MM

    MDR report key: 14934159 · Received July 6, 2022

    Report

    Report Number
    0001825034-2022-01574
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 14, 2022
    Report Date
    July 28, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304474208
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN: COUNTRY: AUSTRALIA . 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2022 -01573.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 8 WEEKS POST IMPLANTATION DUE TO THE ARCOS DISTAL SLOTTED STEM SUBSIDING. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396616 ARCOS CON SZ B STD 80MM PROSTHESIS, HIP JWH ZIMMER BIOMET, INC. N/A 111130 00880304474208

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R CAT# 11-300615 LOT# 363970 STEM