Revitan Modular Revision Hip Systems (2017-01-20)

Starting date:

January 20, 2017

Posting date:

February 1, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-62064

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  Reason
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  Affected products

Affected Products

A. Revitan Modular Revision Hip System-Distal Straight

B. Revitan Modular Revision Hip System-Distal Curved

Reason

This field safety notice is to provide information on the use of the Revitan Revision System and is jointly provided with the latest updated surgical techniques with references 06.01169.012 and 06.01109.012. Zimmer GmbH would like to emphasize that patient selection for modular hip revision systems, such as the Revitan System, is a key parameter. Modular stems have been used in revision surgery for many years and provide advantages for issues that are frequently encountered in a revision setting. However, a modular system also comes with the risk for potential stem fractures. This is a rare complication of modular revision stems caused, most commonly, by large stresses to the modular junction when the proximal component lacks medial bone contact at the calcar. The risk of stem failure is not unique to any one modular system. Bone stock of adequate quality must be present and appraised at the time of surgery. For patients with severe proximal deficiency, a surgeon should consider surgical options to ensure proximal bone support (such as medial and/or lateral strut grafts) or switching to a monobloc revision stem, such as the Wagner SL Revision Hip Stem. Please review the indications and contra indications in the associated surgical techniques and instructions for use of the Revitan Revision System.

Affected products