BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ C STD 60MM

    MDR report key: 19518618 · Received June 12, 2024

    Report

    Report Number
    0001825034-2024-01555
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    May 15, 2024
    Report Date
    October 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304474130
    PMA / PMN Number
    K090757
    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 INFORMATION. MECHANICAL: 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. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT #: 00700007270, LOT #: 65550395, 72MM CUP SIZE REVISION SHELL. CAT #: 00662406525, LOT #: 65959931, BONE SCREW SELF-TAPPING 25 MM LENGTH 6.5 MM DIA. CAT #: 00662406550, LOT #: 63445353, BONE SCREW SELF-TAPPING 50 MM LENGTH 6.5 MM DIA. CAT #: 00662406520, LOT #: 66024209 ,BONE SCREW SELF-TAPPING 20 MM LENGTH 6.5 MM DIA. CAT #: 00662406515, LOT #: 65871275, BONE SCREW SELF-TAPPING 15 MM LENGTH 6.5 MM DIA. CAT #: 00625006535, LOT #: K241829, BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH. CAT #: 00625006530, LOT #: J7488880, BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH. CAT #: P0463058, LOT #: 0001641722, AVAN CMNTD SHELL SS 58MM. CAT #: P0561E58, LOT #: 0001683700, AVAN E1 INSERT 28 S 58. CAT #: 650-1158, LOT #: 3168329, DELTA CER FEM HD 28/0MM T1 UNKNOWN NCB PLATE. G2: FOREIGN: AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. 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 FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 MONTH LATER DUE TO A GREATER TROCHANTER FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389526 ARCOS CON SZ C STD 60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 273660 00880304474130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.