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Ascension
MCP
®
Metacarpophalangeal Joint Implant
Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician .
Instructions For Use
Device Description
®
The Ascension
MCP implant is a two component, semi- constrained,
uncemented, finger joint prosthesis intended to replace the
metacarpophalangeal (MCP) joint of the hand . The proximal component has a
"ball-shaped" articular surface and stem and the distal component has a "cup-
shaped" articular surface and stem . Each component is constructed of a
pyrocarbon layer encasing a high-strength graphite substrate . The Ascension
MCP implant is available in six sizes to accommodate various operative
requirements . Instrumentation, including x-ray templates and color-coded
sizing trials, are available for proper size determination . Intramedullary stem
broaches for each size implant are available to properly prepare the
intramedullary canal . This will help to achieve a "press fit" between the stem of
the device and the intramedullary canal of the bone . No bone cement
is required .
Indications for Use
The Ascension MCP implant is indicated for use as a total joint replacement of
index, long, ring, and small finger metacarpophalangeal (MCP) joints that
exhibit symptoms of pain, limited motion, or inadequate bony alignment
(i . e . , subluxation/dislocation) secondary to articular destruction or
degenerative disease related to rheu matoid arthritis, systemic lupus
erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue
reconstruction can provide adequate stabilization .
Contraindications
• inadequate bone stock at the implantation site
• active infection in the MCP joint
• nonfunctioning and irreparable MCP musculo tendinous system
• physical interference with or by other prostheses during implantation or
use
• procedures requiring modification of the prosthesis
• skin, bone, circulatory and/or neurological deficiency at the
implantation site
Warnings
• Do not modify the Ascension MCP implant in any manner . Reshaping
the implant using cutters, grinders, burrs, or other means will damage
the structural integrity of the device and could result in implant fracture
and/or particulate debris .
• Do not mismatch proximal and distal component sizes . For example, a
Size 10 proximal component should be matched with only a Size 10
distal component . The wear behavior of mismatched proximal and
distal component size combinations has not been evaluated, and is
unknown .
• Do not grasp the Ascension MCP implant with metal instruments, or
instruments with teeth, serrations, or sharp edges . Implants should be
handled only with instrumentation provided by Ascension Orthopedics .
Ascension MCP implants are made of pyrocarbon, which is a ceramic-
like material . Mishandling implants could cause surface damage and
reduce their strength, and could result in implant fracture and/or
particulate debris .
• Do not use Ascension MCP components in combination with proximal
and distal components from other products . The wear behavior of
Ascension MCP components against proximal and distal component
from other products has not been evaluated, and could damage the
structural integrity of the device and result in implant fracture and/or
particulate debris .
Precautions
• Do not use the Ascension MCP implant in a joint where soft tissue
reconstruction cannot provide adequate stabili zation . Similar to the
natural joint, the Ascension MCP implant attains stabilization from the
surrounding capsulo ligamentous structures . Because soft tissue
recon struction may be unable to maintain joint stability, the
Ascension MCP implant is not recommended for use in joints:
• where it is not possible to reconstruct the radial-collateral
ligament, or
• in joints that exhibit extension lag greater than 45 degrees,
• ulnar deviation greater than 30 degrees, or
• severe subluxation and/or shortening greater than 1 centimeter .
• Special attention should be given to soft tissue reconstruction
and joint stability in the ring and small fingers .
• Corrective wrist surgery may be required prior to use of the Ascension
MCP implant . In patients with severe intercarpal supination and radial
deviation of the wrist, ulnar deviation of the digits may not be
correctable with soft tissue reconstruction at the MCP alone . In these
instances, it is recommended that corrective wrist surgery be
performed first at a separate setting .
• Obtain proper training prior to use . Surgeons should obtain training
from a qualified instructor prior to implanting the Ascension MCP
implant to ensure thorough understanding of the indications,
implantation and removal techniques, instrumentation, and post-
operative rehabilitation protocol .
• Inspect the articulating surfaces of the Ascension MCP implant to
insure they are clean and free of all debris prior to use . Foreign debris
could result in excessive wear .
• Do not resterilize this device . Resterilization could lead to mishandling
and surface damage that could result in implant fracture .
• Do not reuse this device . Any implant that has been damaged,
mishandled, or removed from the sterile field may have surface
damage that could result in implant fracture and should be discarded .
Sterilty
This implant has been sterilized by moist heat . If either the implant or the
package appears damaged, or if sterility is questioned for any reason, the
implant should not be used . Resterilization of this product is not
recommended .
Adverse Events
The sponsor used an earlier version of the Ascension MCP device clinically .
Therefore, the reported adverse effects identified in this section are those
observed while using the earlier device design . For clarity, the earlier device
design is designated as the "Pyrocarbon MCP . "
Reported Adverse Effects
The most commonly reported patient adverse events were:
• recurrent deformity
• subluxation / dislocation
• re-operation for soft tissue reconstruction
• implant removal
• implanted joint pain, and
• synovitis
A detailed discussion and complete list of the frequency and rate of
complications and adverse events identified in the case history review is
provided below in section 7 Clinical Case Studies .
Potential Adverse Effects
Potential adverse effects associated with total joint prostheses and surgery
in general include, but are not limited to:
• pain
• bleeding
• infection
• swelling
• damage to surrounding blood vessels, nerves, or soft tissue
• implant migration within the bones
• implant loosening
• excessive implant wear and particulate
• allergic or foreign body reaction
• implant fracture
• bone fracture
• implant subluxation or dislocation
• finger deformity (radial or ulnar deviation, supination or pronation)
• reduction or loss of joint motion
• loss of finger or hand function
• lengthening or shortening of the finger
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