BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACTOR ADAPTER- S/B

    MDR report key: 10377134 · Received August 6, 2020

    Report

    Report Number
    3007521480-2020-00010
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 11, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00858704006565
    PMA / PMN Number
    K172462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONLY THE IMPACTOR ADAPTOR WAS RETURNED. UPON VISUAL INSPECTION, THE THREADS OF THE ADAPTOR LOOK TO BE COMPLETELY INTACT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION IF ALERT LIMITS ARE EXCEEDED.

    Additional Manufacturer Narrative · 1

    THE REPORTED INABILITY TO DISASSEMBLE THE CUP WILL BE INVESTIGATED ONCE THE PRODUCT IS RETURNED. ORTHALIGN IS FILING THIS MDR IN AN ABUNDANCE OF CAUTION DUE TO THE OUTCOME OF THIS CASE AND THE POTENTIAL CONNECTION TO THE HIPALIGN SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN. AFTER CUP IMPACTION WITH 48MM CUP, THE SURGEON TRIED TO DISENGAGE FROM CUP AND IMPACTOR. HOWEVER, HE WAS UNABLE TO DISASSEMBLE THE CUP. SUBSEQUENTLY, TWO SURGEONS DISENGAGED THE CUP WITH FORCE. THE PATIENT ACETABULAR WAS LITTLE DAMAGED BY DISASSEMBLY SO BIGGER CUP (50MM) WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835970 IMPACTOR ADAPTER- S/B IMPACTOR ADAPTER OLO ORTHALIGN, INC. 403028 10808VZ 00858704006565

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention