Events

Recall of OtisMed ShapeMatch Cutting Guides (used to assist in the positioning of knee arthroplasty components and in guiding the marking of bone before cutting)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00859-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00859-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    In april 2013, stryker orthopaedics issued a safety alert (tga ref.: rc-2013-rn-00323-1) to users to request that a hold be placed on further procedures using otismed shapematch cutting guides to investigate the product experience reports received from customers. stryker orthopaedics stated that further information would be provided on completion of the investigation. the investigation identified that the surgical protocol for the shapematch cutting guides did not provide sufficient information on the position of the cutting guide, the need for osteophyte/soft tissue removal, the requirement for proper axial drilling, and the need to avoid angulation and mal-alignment. the approved pre-operative plan did not provide sufficient information regarding the need for osteophyte removal. the values displayed via the otismed.Net web portal were inconsistent with the pre-operative planning values used to manufacture some of the shapematch cutting guides.
  • Action
    The pre-operative plan and surgical protocol has been revised to include the information identified during the investigation e.g., addition of warnings, inclusion of additional text including new images to better illustrate the issues. Surgeons are advised that no additional patient follow-up or monitoring is required apart from usual routine follow-up, which will identify any issue. Stryker is advising that symptomatic patients will present to their Health Care Practitioner. If any potential hazard or harms are detected by the Health Care Practitioner the appropriate action shall be taken. For more details, please see http://www.tga.gov.au/safety/alerts-device-otismed-shapematch-130826.htm .

Device

OtisMed ShapeMatch Cutting Guides (used to assist in the positioning of knee arthroplasty compone...
  • Model / Serial
    OtisMed ShapeMatch Cutting Guides (used to assist in the positioning of knee arthroplasty components and in guiding the marking of bone before cutting)Catalogue Number: TR3100-L & TR3100-RARTG Number: 179665
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA