Instructions For Use - acumed Anatomic Radial Head System Gebrauchsanweisung

EN
Anatomic Radial Head System, Anatomic Radial Head Solutions, Anatomic Radial Head
Solutions 2
These instructions are intended for the Operating Surgeon and supporting Healthcare Professionals.
EN
The EN instructions are intended for users in English speaking countries outside the United States
and its territories.
DESCRIPTION
Acumed Anatomic Radial Head implants and instruments are designed to replace the articular surface of the
radial head.
INDICATIONS FOR USE
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.
The implant is intended to be press fit or cemented.
CONTRAINDICATIONS
• Active or latent infection
• Sepsis
• Insufficient quantity or quality of bone, osteoporosis
• Soft tissue or material sensitivity
• Patients who are unwilling or incapable of following post-operative care instructions
WARNINGS & PRECAUTIONS
Warning:
• The treatment or implant may fail, including sudden failure, as a result of:
- Loose fixation and/or loosening
- Stress, include stress from inappropriate bending of the implant during surgery
- Stress concentrations
- Stress of weight bearing, load bearing, or excessive activity
• Failure is more likely if the implant experiences increased loads due to delayed union, nonunion, or
incomplete healing. Failure is more likely if the patient does not follow post-operative care instructions.
• Nerve or soft tissue damage may result from surgical trauma or the presence of an implant.
• Instrument breakage or damage, as well as tissue damage, may occur when an instrument is subjected to
excessive loads, excessive speeds, dense bone, improper use or unintended use.
• Implants may cause distortion and/or block the view of anatomic structures on radiographic images.

Instructions for use

English (non-U.S.) – EN / PAGE 43