Contraindications; Ti6Al4V; Uhmwpex; Uhmwpe X-Lima +Ti6Al4V - Limacorporate SMR Gebrauchsanweisung

Schultersystem

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Verfügbare Sprachen

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SMR TT Metal Back Peg

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SMR Metal Back Liner

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SMR Glenoid Plates

Material Standards

Ti6Al4V (ISO 5832-3 – ASTM F1472) – CoCrMo (ISO 5832-12 – ASTM F1537) – Ti (ASTM F67) –

UHMWPE (ISO 5834-2 – ASTM F648) – Alumina (ISO 6474) – PoroTi Titanium Coating (ASTM F1580)

– HA Hydroxyapatite Coating (ISO 13779)

A = Anatomic; R = Reverse; C = Cemented; NC = Not Cemented

* Not available in EU.

2.2. CONTRAINDICATIONS

Absolute contraindications include: • local or systemic infection; • septicaemia; • persistent acute or chronic

osteomyelitis; • confirmed nerve lesion compromising shoulder joint function; • deltoid muscle insufficiency.

Relative contraindications include: • vascular or nerve diseases affecting the concerned limb; • poor bone stock

(for example due to osteoporosis or extended previous revision surgery) compromising the stability of the

implant; • metabolic disorders which may impair fixation and stability of the implant; • any concomitant disease

and dependence that might affect the implanted prosthesis; • metal hypersensitivity to implant materials.

In cases of bone tumors, use an appropriate system designed to treat cases requiring large bone resections

(SMR Large Resections stems). The use of primary or revision implants not designed and intended for use

in cases of bone resection may result in a poor outcome and / or failure of the implant or implant fixation.

2.3. RISK FACTORS

The following risk factors may result in poor results with this prosthesis: • overweight; • strenuous

physical activities (active sports, heavy physical work); • incorrect implant positioning; • wrong size

of components; • muscle deficiencies; • multiple joint disabilities; • refusal to modify postoperative

physical activities; • patient history of infections or falls; • systemic diseases and metabolic disorders;

• local or disseminated neoplastic diseases; • drug therapies that adversely affect bone quality, healing, or

UHMWPE

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