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ARTICLE · 13 OCTOBER 2020

Field Safety Notice: Inspyre ™: Pyrocarbon Interpositional Implant

Leigh Day
Leigh Day
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Leigh Day

Leigh Day

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Tornier SAS, the manufacturer of the Insypre ™ shoulder prosthesis, published a Field Safety Notice on 23 September 2020 to alert physicians to changes for its use.

United KingdomConsumer Protection

Tornier SAS, the manufacturer of the Insypre " shoulder prosthesis, published a Field Safety Notice on 23 September 2020 to alert physicians to changes for its use. The notice is available on the MHRA website.

The Insypre shoulder prosthesis implant is used for the partial replacement of the ‘glenohumeral joint', also known as the ‘ball' in the ball and socket joint in the shoulder. Replacement of the ball is intended to be used to reduce pain to and improve mobility in the recipient and has been implanted in those suffering from rheumatoid arthritis in the joint.

The manufacturer has now highlighted that a potential hazard of implanting this device in patients with rheumatoid and osteoarthritis is that it can have poor clinical results and can lead to individuals experiencing pain which could result in revision surgery being required.

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