BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ A STD 70MM

    MDR report key: 18779327 · Received February 26, 2024

    Report

    Report Number
    0001825034-2024-00525
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    February 5, 2024
    Report Date
    June 14, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304474314
    PMA / PMN Number
    K090757
    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). D10: 11-301815 ARCOS 15X200MM INTLKNG DIST 358810 166066 ARCOS DISTAL SCREW TI 5X30MM M 7032012 166067 ARCOS DISTAL SCREW TI 5X35MM M 6973109 G2: FOREIGN: AUSTRALIA MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2024 - 00525 0001825034 - 2024 - 00528 0001825034 - 2024 - 00529 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PROPOSED COMPONENT CODE: MECHANICAL (G04): STEM. TWO IMAGES OF THE EXPLANTED STEM WERE SUPPLIED WITH THE X-RAYS; THE IMAGE SHOWS THE CONE BODY SEPARATED FROM THE STEM. THE PHOTOS ALSO SHOW THE CERAMIC HEAD, BUT NO INFORMATION ABOUT THE HEAD CAN BE OBTAINED FROM THE IMAGE. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. IMPRESSIONS: LEFT HIP ARTHROPLASTY WITH SUBSIDENCE OF THE FEMORAL IMPLANT AND SUSPECTED RETRACTION OF THE DISTAL FEMORAL SCREWS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, IT WAS NOTED THAT A DEPUY LINER WAS USED WITH ZIMMER BIOMET HIP COMPONENTS, AND THIS IS CONSIDERED OFF-LABEL USE AS ¿THE SYSTEM IS USED WITH BIOMET TYPE 1 TAPER MODULAR HEADS AND COMPATIBLE BIOMET ACETABULAR SHELLS/LINERS AND SCREWS¿, IT IS UNKNOWN IF THIS OFF LABEL USE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. EVENT IS CONFIRMED VIA MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD AN INITIAL TOTAL LEFT HIP ARTHROPLASTY PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN IMPLANTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE ASSOCIATED WITH LOOSENING STEM. THE PATIENT WAS IMPLANTED WITH ZIMMER BIOMET DEVICES DURING THE REVISION SURGERY AND WAS REVISED FOR A SECOND TIME THREE YEARS POST IMPLANTATION FOR IMPLANT SUBSIDENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212439 ARCOS CON SZ A STD 70MM PROTHESIS, HIPS KWA ZIMMER BIOMET, INC. N/A 626650 00880304474314

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| H SEE H10 NARRATIVE