BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 15X190MM SPL TPR DIST

    MDR report key: 17011000 · Received May 26, 2023

    Report

    Report Number
    0001825034-2023-01214
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    March 14, 2023
    Report Date
    August 30, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304480513
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ STEM. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO 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 WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, THE PATIENT HAS A CONDITION DDH THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 11-301300 ARCOS CON SZ A STD 50MM 270030; 163661 28MM DIA COCR MOD HD -3MM NK J7307527; 010001000 G7 SCREW 6.5MM X 35MM 7309504; 010000999 G7 SCREW 6.5MM X 30MM 7333331; 010000913 G7 HI-WALL E1 LINER 28MM A 7099066; 110010260 G7 OSSEOTI MULTIHOLE 44MM A 7240179; 000-0163 PELVIC SCREW STD 116MM 9999999999; 010000997 G7 SCREW 6.5MM X 20MM 7199540. G2: FOREIGN: AUSTRALIA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 01178, 0001825034 - 2023 - 01213. 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 · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST IMPLANTATION OF A HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO SCIATIC PAIN. THE CONE BODY, HEAD, AND STEM WERE EXPLANTED FROM THE PATIENT. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575889 ARCOS 15X190MM SPL TPR DIST PROTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 004150 00880304480513

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| H SEE H10 NARRATIVE