Contraindications - Depuy Synthes Delta Xtend Bedienungsanleitung

ENGLISH
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
GENERAL REMARKS
It is essential that the surgeon is fully conversant with the prescribed surgical technique and
that due consideration is given to the information provided below. Improper patient selection
with particular regard to patient weight and functional demands, as well as placement and
positioning of the implant may result in unusual stress conditions and subsequent reduction in
their functional life.
Warnings and instructions should be strictly observed.
DEVICE DESCRIPTION
TOTAL SHOULDER PROSTHESIS:
The Total Shoulder Prosthesis consists of individually packaged implants: a metal monobloc
humeral implant (cobalt- chromium), or a metal humeral stem (titanium alloy) associated with a
metal humeral epiphysis (titanium alloy), a glenosphere (cobalt-chromium), a metaglene (titanium
alloy) and metaglene screws (titanium alloy) in combination with an Ultra High Molecular Weight
Polyethylene (UHMWPE) humeral cup and an optional metal humeral spacer (titanium alloy).
HEMI‑SHOULDER PROSTHESIS:
The Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal monobloc
humeral implant (cobalt- chromium), or a metal humeral stem (titanium alloy) associated with
a metal humeral epiphysis (titanium alloy), or a metal humeral head (cobalt-chromium) and an
optional metal humeral spacer (titanium alloy) (no glenoid component associated).
INTENDED USE:
The DePuy Delta Xtend Shoulder Prosthesis is intended for use in total shoulder or hemi-shoulder
replacement procedures in patients with non-functional rotator cuffs, with or without bone
cement. HA components are for cementless use only.
INDICATIONS FOR USE:
The Delta Xtend Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff
joint with:
• severe arthropathy and/or;
• a previous failed joint replacement and/or;
• Fracture-dislocations of the proximal humerus where the articular surface is severely
communited, separated from its blood supply or where the surgeon's experience indicates that
alternative methods of treatment are unsatisfactory
The patient's joint must be anatomically and structurally suited to receive the selected implant(s),
and a functional deltoid muscle is necessary to use the device.
Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is
fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder.
The metaglene component is HA coated and is intended for cementless use with the addition
of screws for fixation. The modular humeral stem and humeral epiphysis are HA coated and are
intended for cementless use.
All other metallic components are intended for cemented use only.

CONTRAINDICATIONS

Joint replacements may be contraindicated where the patient is overweight, where there is
infection, poor bone stock, severe deformity, drug abuse, overactivity, tumor, mental incapacity,
muscle, nerve or vascular disease.
Note: Diabetes, at present, has not been established as a contraindication. However, because of
increased risk for complications such as infection, slow wound healing, etc., the physician should
carefully consider the advisability of shoulder replacement in the severely diabetic patient.
WARNINGS AND PRECAUTIONS
CAUTION:
Implants and trial components from different manufacturers or implant systems should
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never be used together, with the exception of Global Unite humeral stems and DELTA CTA
as described below.
When well‑fixed, the Global Unite humeral stems, in conjunction with existing
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Delta Xtend epiphyseal components, can be used when conversion to a reverse
is necessary.
When well‑fixed DELTA CTA stem, the DELTA Xtend glenosphere and metaglene
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can be used with DELTA CTA Hybrid Humeral PE cups, Humeral PE cups dia 42mm
and/or spacers described in the DELTA Xtend Addenda Surgical Technique.
Shoulder prosthesis components should never be reimplanted. Even though the implant
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appears undamaged, the implant may have developed microscopic imperfections, which
could lead to failure. DePuy's Single Use devices have not been designed to undergo
or withstand any form of alteration, such as disassembly, cleaning or re‑sterilization,
after a single patient use. Reuse can potentially compromise device performance and
patient safety.
• Always use a trial prosthesis for trial purposes. Trials should not be assembled with
any components intended for permanent implantation. Trials must have the same
configuration size, etc., as the corresponding components to be implanted.
• Do not alter or modify implants in any way.
• The use of a glenoid prosthesis in patients with cuff tear arthropathy could increase the
risk of glenoid component loosening due to non‑anatomic loading conditions.
INSTRUCTIONS FOR USE
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