BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 32MM RLOC LNR 10D/HWL 23

    MDR report key: 11130887 · Received January 7, 2021

    Report

    Report Number
    0001825034-2021-00023
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    January 21, 2021
    Report Date
    April 2, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 15 YEARS AGO. SUBSEQUENTLY, PATIENT HAS DISLOCATED TWICE IN THE PAST TWO MONTHS AND UNDERWENT REVISION SURGERY. THE HEAD, LINER, AND SHELL WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). BIOMET 32MM MOD HEAD COCR STD NECK CAT#163669 LOT#485990 BIOMET RCOM 32MM RLOC LNR 10D/HWL 23 CAT#11-105873 LOT#179100 BIOMET M/H RADIAL 3-HOLE SHELL 58MM CAT#12-104158 LOT#890150 BIOMET TI LOW PROFILE SCREW 6.5X20MM CAT#103531 LOT#587970 BIOMET TI LOW PROFILE SCREW 6.5X20MM CAT#103531 LOT#384620 BIOMET INTEGRAL/X POR STANDARD 12MM CAT#X170312 LOT#533590 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 00022

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 15 YEARS AGO. SUBSEQUENTLY, PATIENT HAS DISLOCATED TWICE IN THE PAST TWO MONTHS. AN UPCOMING REVISION SURGERY IS SCHEDULED FOR LATER THIS MONTH. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31772 ARCOM 32MM RLOC LNR 10D/HWL 23 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 179100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R SEE H10 NARRATIVE| SEE H10 NARRATIVE