BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ E HI 70MM

    MDR report key: 20517025 · Received October 23, 2024

    Report

    Report Number
    0001825034-2024-02493
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    October 4, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304480483
    PMA / PMN Number
    K090757
    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). G2: FOREIGN: COUNTRY: AUSTRALIA. D10: CAT# 11-300918 LOT# 65688209 ARCOS 18X190MM SPL TAPER DIST. CAT# 31-302001 LOT# UNKNOWN ARCOS PROX DST STEM INSERTER. 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 INFORMATION. H6: COMPONENT CODE: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED FOR EVALUATION. HOWEVER, PICTURES WERE PROVIDED OF THE INSERTER. A VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED AN INSERTER WITH COSMETIC DAMAGE/BURRS ON THE TIP. NO FURTHER EVALUATION COULD BE MADE FROM THE PROVIDED PHOTOS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROXIMAL BODY/DISTAL STEM IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. LOT NUMBER IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY; HOWEVER, NO LOT NUMBER WAS PROVIDED FOR THE INSERTER. RADIOGRAPHS WERE PROVIDED BUT WERE NOT REVIEWED BY A HEALTH CARE PROFESSIONAL DUE TO THE IMAGE BEING UNDATED; IT WAS UNCLEAR WHETHER THE PRE OR POST REVISION WAS REPRESENTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED BASED ON THE PHOTOGRAPH OF THE DAMAGED INSERTER. 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 THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE. DURING THE PROCEDURE, THERE WAS ISSUES WITH THE INSERTER. ATTEMPTS WERE MADE TO FIX THE PROXIMAL BODY TO THE DISTAL STEM IN A REAM-OVER TECHNIQUE. HOWEVER, IT WOULD NOT WORK DESPITE THE TECHNIQUE BEING UTILIZED. MULTIPLE ATTEMPTS WERE TRIED TO ASSEMBLE THE CORRECT INSTRUMENTATION TO NO AVAIL. THE SURGEON THEN ATTEMPTED TO FIX THE PROXIMAL BODY TO THE DISTAL STEM USING A BASTARDIZED TECHNIQUE TO FIX THE STEM AND PROXIMAL BODY TOGETHER. THERE WAS A 25-MINUTE DELAY DURING SURGERY DUE TO INSTRUMENTATION NOT WORKING. AFTER THE CASE, IT WAS DETERMINED THAT THE GREY INSERTION HANDLE WAS DAMAGED AND BURRED AT THE INSERTION END WHICH DID NOT ALLOW THE ASSEMBLY ROD TO ENTER. THERE WAS NO DAMAGE NOTED TO THE INSTRUMENT PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE STEM OR PROXIMAL BODY IMPLANTS. THE FOLLOWING DAY, AN X-RAY SHOWED THAT THE STEM AND PROXIMAL BODY HAD A DUBIOUS COUPLING. IT WAS ALSO NOTED THAT THE PROXIMAL BODY WAS HUNG UP ON THE MEDIAL CALCAR AND WAS NOT SEATED IN THE PROXIMAL REAMED BONE. THE SURGEON ELECTED TO DO A REVISION THE NEXT DAY DUE TO CONCERNS THAT THE CONSTRUCT MAY FAIL IN THE LONG RUN, AND THE STEM AND PROXIMAL BODY WERE LOOSE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322076 ARCOS CON SZ E HI 70MM PROTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 66623727 00880304480483

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention| H