Indications And Contraindications - Zimmer Biomet A.L.P.S. Surgical Technique

A.L.P.S. Hand Fracture System
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Instrument Lifespan: For information in determining
whether a reusable instrument is no longer suitable
for use, reference Reusable Instrument Lifespan
Manual (1219.1-GLBL-en) which can be found at
www.zimmerbiomet.com
INDICATIONS
The ALPS Hand System is indicated for stabilization
and fixation of small bone fragments in fresh
fractures, revision procedures, joint fusion and
reconstructions of small bones of the hand, foot,
wrist, ankle, humerus, scapula, finger, toe, pelvis
and craniomaxillofacial skeleton, particularly in
osteopenic bone.
CONTRAINDICATIONS
(orthopaedic screws, intramedullary nails, plates,
compression hip screws, pins and wires):
• Cases where there is an active infection.
• Conditions which tend to retard healing such as,
blood supply limitations, previous infections, etc.
• Insufficient quantity or quality of bone to permit
stabilization of the fracture complex and/or fusion
of the joints.
• Conditions that restrict the patient's ability or
willingness to follow postoperative instructions
during the healing process.
• Foreign body sensitivity – where material sensitivity
is suspected, appropriate tests should be made
and sensitivity ruled out prior to implantations.
• Cases where the implant(s) would cross open
epiphyseal plates in skeletally immature patients.
ADDITIONAL CONTRAINDICATIONS –
Orthopaedic Screws and Plates Only:
• Cases with malignant primary or metastatic
tumors which preclude adequate bone support
or screw fixations, unless supplemental fixation or
stabilization methods are utilized.
POSSIBLE ADVERSE EFFECTS
(orthopaedic screws, intramedullary nails, plates,
compression hip scres, pins and wires):
• Loosening, bending, cracking or fracture of the
orthopaedic screw, intramedullary nail, plate, and
screw-plate combination or loss of fixation in bone
attributable to nonunion, osteoporosis, markedly
unstable comminuted fractures.
• Loss of anatomic position with nonunion or malunion
with rotation or angulation.
• Infection, both deep and superficial.
• Allergies or other reaction to the device material.
• Surgeons should take care when targeting and
drilling for the proximal screws in any tibial nail with
oblique proximal screws. Care should be taken as
the drill bit is advanced to penetrate the far cortex.
Advancing the drill bit too far in this afea may cause
injury to the deep peroneal nerve. Fluoroscopy
should be used to verify correct positioning of the
drill bit.
ADDITIONAL POSSIBLE ADVERSE EFFECTS
FOR COMPRESSION HIP SCREW ONLY:
• Screw cutout of the femoral head (usually
associated with osteoporotic bone). In using partial
weight bearing or nonweight bearing appliances
(orthopaedic devices other than prostheses) a
surgeon should be aware of the following:
1. NO PARTIAL WEIGHT BEARING OR NONWEIGHT
BEARING DEVICE CAN BE EXPECTED TO
WITHSTAND THE UNSUPPORTED STRESSES OF
FULL WEIGHT BEARING. Until firm bone union
is achieved, the patient should employ adequate
external support and restrict physical activities
which would place stress upon the implant or allow
movement at the fracture site and delay healing.
Failure to immobilize a delayed union or nonunion
of bone will result in excessive and repeated
stresses which are transmitted by the body to
any temporary internal fixation device prior to
the healing of the fracture. Due to normal metal
fatigue, these stresses can cause eventual
bending or breakage of the device. Therefore, it
is important that immobilization of the fracture
site is maintained until firm body union (confirmed
by clinical and roentgenographic examination) is
established.