Contraindications; English- En - acumed Anatomic Radial Head System Handbuch

EN
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ACUMED ANATOMIC RADIAL HEAD SYSTEM, ANATOMIC RADIAL HEAD SOLUTIONS,
ANATOMIC RADIAL HEAD SOLUTIONS 2
FOR THE PERSONAL ATTENTION OF THE
OPERATING SURGEON AND SUPPORTING
HEALTH CARE PROFESSIONALS
DESCRIPTION: Acumed Anatomic Radial Head implants and
instruments are designed to replace the articular surface of the
radial head.
INDICATIONS: The Acumed Anatomic Radial Head System,
Anatomic Radial Head Solutions, and Anatomic Radial Head
Solutions 2 and accessories are designed specifically for (1)
Replacement of the radial head for degenerative or post-traumatic
disabilities presenting pain, crepitation, and decreased motion at
the radio-humeral and/or proximal radio-ulnar joint with: joint
destruction and/or subluxation, resistance to conservative
treatment, (2) Primary replacement after fracture of the radial
head, (3) Symptomatic sequelae after radial head resection,
(4) Revision following failed radial head arthroplasty.
CONTRAINDICATIONS: Contraindications for the system are
active or latent infection; sepsis; osteoporosis, insufficient quantity
or quality of bone or soft tissue and material sensitivity. If material
sensitivity is suspected, tests should be performed prior to
implantation. Patients who are unwilling or incapable of following
postoperative care instructions are contraindicated for these
devices. These devices are not intended for screw attachment or
PKGI-42-T Effective 08-2019
fixation to the posterior elements (pedicles) of the cervical,
thoracic, or lumbar spine.
IMPLANT MATERIAL SPECIFICATIONS: The implants are
made of titanium alloy per ASTM F136 or cobalt chrome per
ASTM F1537.
SURGICAL INSTRUMENT MATERIAL SPECIFICATIONS: The
instruments are made of various grades of stainless steel,
titanium, aluminum, and polymers evaluated for biocompatibility.
IMPLANT INFORMATION FOR USE: Physiological dimensions
limit the sizes of implant appliances. The surgeon must select the
type and size that best meets the patient's requirements for close
adaptation and firm seating with adequate support. Although the
physician is the learned intermediary between the company and
the patient, the important medical information given in this
document should be conveyed to the patient.
SURGICAL INSTRUMENT INFORMATION FOR USE: Instruments
provided with this system may be single use or reusable.

The user must refer to the instrument's label to determine
whether the instrument is single use or reusable. Single use
instruments are labeled with a "do not re-use" symbol as
described in the Symbol Legend section, below.
English– EN/ PAGE 19