Limacorporate SMR Gebrauchsanweisung Seite 4

The device's code and lot number should be recorded in the patient's case history by using the labels included
in the component packaging. The disposal of medical devices is to be performed by the hospitals in conformity
with applicable laws.
Re-use of previously implanted devices must be absolutely avoided. Risks associated with reuse of
single use devices are: • infection; • early or late failure of the device or device fixation; • lack of
appropriate coupling between modular junctions (e.g. taper connections); • device wear and wear
debris associated complications; • transmission of diseases (e.g. HIV, hepatitis); • immune system
response / rejection.
2. GENERAL INFORMATION ON INDICATIONS, CONTRAINDICATIONS AND RISK FACTORS
2.1. INDICATIONS
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement in
skeletally mature patients. The SMR Anatomic Shoulder System is indicated for partial or total, primary or
revision shoulder joint replacement in patients suffering from disability due to: • non-inflammatory degenerative
joint disease including osteoarthritis and avascular necrosis; • inflammatory degenerative joint disease such
as rheumatoid arthritis; • treatment of acute fractures of the humeral head that cannot be treated with other
fracture fixation methods; • revision of a failed primary implant; • cuff tear arthropathy (CTA Heads only).
The Large Resection Stems are indicated for oncology applications.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement
in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must
be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is
necessary to use the device. The Modular SMR Shoulder System allows the assembly of components in
various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as
specified in the following table. In the Anatomic shoulder the humeral construct consists of the humeral stem,
the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct
consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation
of the humeral stem determines if the construct is cemented or uncemented. The Anatomic glenoid construct
consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid
construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of
the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented. The
intended use of the Glenoid Bone Graft Instruments (not approved in Canada) is to enable the preparation of
the bone graft from the patient's humeral head or allograft from the bone bank, to restore the glenoid anatomy
in case of glenoid deficiency (e.g. glenoid type B2 or C according to Walch's classification). The Glenoid Bone
Graft Instruments are intended to be used only with Axioma TT Metal Back and L1 TT Metal Back.
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