JRI Furlong H-A.C. Revision Hip Stems & Securus User manual

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155-030 ISSUE 6 (June 2012)
CAUTION: Federal law (USA) restricts this device
to sale by or on the order of a physician.
JRI ORTHOPAEDICS LIMITED
18 CHURCHILL WAY
35A BUSINESS PARK
CHAPELTOWN
SHEFFIELD
S35 2PY
TEL [phone]
FAX [phone]
www.jri-ltd.co.uk
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ENGLISH
Furlong® H-A.C. Revision Hip Stems & Securus Revision Hip System
Important Information: Please read prior to use in a clinical setting. The Surgeon should
be familiar with the operative technique.
Description: Furlong® H-A.C. revision stems are monobloc and comprise the following range in
different distal diameters and with different neck angles and offsets: Straight monobloc stems,
in standard and Plus proximal body sizes.
Securus revision stems are either monobloc or modular and comprise the following range in
different distal diameters and with different neck angles and offsets: A-P bowed monobloc
stems with anteversion and holes in the distal stem for anti-rotation screw fixation and a range
of modular components.
The modular range consists of various sizes of proximal body and distal stems, in various lengths
and a range of diameters, which are all interchangeable. The proximal body is locked to the distal
diameter by a tapered interface and the use of a through locking bolt. The assembled stems all
have distal screw fixation capability.
All revision stems with distal screw fixation capability have a screw connection in the proximal
body superiorly for attachment of a distal targeting jig. The range incorporates a cap to seal
offthis screw connection after the stem has been implanted.
A range of lengths of Cortical Anti-Rotation Screws are available for use for distal screw fixation.
Bone Substitute materials are available to supplement this system where required.
The Furlong® H-A.C. and Securus Revision Stems are collared prostheses made of Titanium
alloy Ti-6Al-4V and fully coated with Hydroxy-apatite Ceramic CA5OH(PO4)3.
The Securus modular revision stems are comprised of proximal body and distal stem sections. All
proximal body and distal stem components of the modular revision system are made of Titanium
alloy Ti-6Al-4V and fully coated with Hydroxy-apatite Ceramic CA5OH(PO4)3apart from the
interfaces which are free from coating.
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All stems are for use WITHOUT cement, long term fixation being achieved through bone
ingrowth and union of the coating and the host bone. Stems are available in various sizes to
accommodate anatomical variations of the femur.
IMPORTANT: Adjunctive proximal fixation / support is required for Size 10, 11 and 12 monobloc,
11mm and 12mm diameter modular 250mm length stems and 13mm diameter 300 length
modular stems and is recommended for all the Securus and Furlong® H-A.C. revision stems,
both monobloc and modular. Where there is loss of proximal bone stock, or poor proximal bone
quality, bone grafting or other adjunctive proximal fixation / support is advised for implant
stability. It is important that the prosthesis is not distally fixed without proximal support.
A range of Furlong® H-A.C. Acetabular Cups are available for use with this system, refer to
155-019.
Femoral Heads of various diameters and neck lengths are available for use with this system in
Cobalt Chrome alloy or ceramic. Ceramic heads are made from alumina ceramic or Biolox delta.
Special Instructions For Use are required for ceramic heads refer to 155-020. JRI recommend
the use of highly crosslinked UHMWPE (CLP-75) with larger metal head diameters because of
reduced volumetric wear.
Bone Substitute granules, blocks and pastes are available for use with this system, please
refer to 155-028.
All types of bone screw are available in a variety of lengths and are manufactured from Titanium
alloy Ti-6Al-4V, as are the modular revision connection screw and blanking plug.
Smaller sized implants are intended for patients with smaller bone and regular Body Mass Index
and could be inappropriate for other patients.
Note: Components should only be used with other compatible components of the Securus and
Furlong® H-A.C THR Systems, with the corresponding taper connections. Implant components
from one manufacturer MUST NOT be used together with those of another manufacturer,
since compatibility of mating parts cannot be assured except for product combinations
specifically tested and approved by JRI.
Symbols: 5 = 5mm lateral offset, 133 = 133° Neck angle
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Indications: The Securus and Furlong® H-A.C. Revision hip stems are indicated for, but not
limited to the following conditions:
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-
arthroplasty, surface replacement arthroplasty, or total hip replacement. Distal locking screws
are indicated for implants where a greater degree of torsional stability is required.
Note: This device is to be used only under the control and supervision of an accredited
Orthopaedic Surgeon. The medical team have a duty of care towards their patient which includes
the following: A responsibility to diagnose appropriately the necessity for the implantation of
this device, bearing in mind any indications and contra-indications present in any particular
patient; to carry out a full and adequate consultation with the patient before surgery, explaining
the risks and consequences of the surgical procedure and the longevity of the implant and any
factors affecting the same; to use an appropriate operative technique, and implement a suitable
post-operative regime with appropriate follow up and monitoring for any adverse effects of
surgery. As a manufacturer of the product, JRI take no responsibility for any damage, breakage
or adverse affects caused as a result of any failure in the medical team to discharge such duty.
Patients receiving hip joint replacements should be advised before surgery that the longevity of
the implant might depend on their weight and level of activity. Patients with high-activity level
and/or higher weight patients are at greater risk for implant complications or failures.
Contra-indications: The device should not be implanted where there is active infection,
insufficient bone stock to support the prosthesis or provide adequate fixation. Further contra-
indications may be, but are not limited to the following conditions:
1. Severe deformities.
2. Severe Osteoporosis.
3. Tumours.
4. Systematic and metabolic disorders.
5. Obesity.
6. Drug addiction.
Important notice: Important notice for the implantation of the Securus, Furlong® H-A.C.
Coated or Furlong® Active Femoral Stems. Please read this notice which was issued by
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