BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RNGLOC LNR HWALL 24

    MDR report key: 15079543 · Received July 21, 2022

    Report

    Report Number
    0001825034-2022-01670
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    June 29, 2022
    Report Date
    September 6, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: CATALOG NUMBER:XL-105914 LOT NUMBER:366420 BRAND NAME: ARCOMXL 36MM RLC LNR HW. CATALOG NUMBER:650-1057 LOT NUMBER:3094040 BRAND NAME: CER BIOLOXD OPTION HD. CATALOG NUMBER:650-1064 LOT NUMBER: 3100139 BRAND NAME: CER OPTION TYPE 1 TPR. 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D4, G3, G6, H2, H3, H4, H6, H10 VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE LINER HAS DAMAGE, DEFORMATION, AND FLAKING. REVIEW OF THE RADIOGRAPHS PROVIDED THE FOLLOWING: OVERALL SIZE OF BOTH IMPLANTS IS APPROPRIATE. POLYETHYLENE WEAR OF THE ACETABULAR CUPS IS NOTED. THERE ARE NO OTHER CONCERNS OR ISSUES IDENTIFIED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 THAT THE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR APPROXIMATELY 15 YEARS POST IMPLANTATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555199 ARCOM 28MM RNGLOC LNR HWALL 24 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 567700

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H