EXECUTIVE SUMMARY

HIP IMPLANT
Product Name : Artificial Hip Prosthesis
Models and specifications See List of models and specifications for JUST Artificial
Hip Prosthesis
Production license : No. 20100058
Registration certificate : No. 2012 3461604
Registration standard : YZB/5747-2012
Manufacturer : JUST HUAJIAN MEDICAL DEVICE (TIANJIN) CO., LTD.
Registered trademark
Registered address, Manufacturer address & contact information
Address
Telephone
Fax

: No.27, Ziyang Road, Nankai District, Tianjin, R. P. China

: 86-22-27636145 23399501 23399502
: 86-22-27369135 Postcode: 300190

Performance, structure of the product

The materials of this total hip prosthesis are Titanium Alloy, CoCrMo Alloy
and Ultra-High Molecular Weight Polyethylene (UHMWPE). Total hip prosthesis
components include femoral stem,
femoral head,
bipolar head,
acetabular cup, monopolar head, liner, acetabular screw, which all have
many specifications for use.
CAUTION: Use only JUST femoral heads with JUST femoral stems. JUST femoral
stem attaches with JUST femoral head by a taper of 54329. JUST products
should not be used with products of other brands because of the production
tolerance, even with the same taper.
Indications
1. Organic disease of hip joint;
2. Hip joint trauma;
3. Patient without obvious osteoporosis;
4. All patients require total hip arthroplasty

due to end-stage hip diseases,

meantime without contraindications of total hip arthroplasty;
5. Non allergic reactions to implant materials;
6. Whose survival period after total hip arthroplasty is estimated to be more than
2 years;
7. Other diseases surgeon convinced require total hip arthroplasty.

Complications
1. Common risks may occur in all surgical procedures;
2. Specific complications in total hip arthroplasty

A) Adverse reactions secondary to material wear over time;

B) Loosening of the implant due to various reasons.
Contraindications
1. Cerebral palsy
2. General or local infections, acute or chronic;
3. Severe osteoporosis;
4. Other conditions surgeon decides not suitable for surgical procedures.

Information for Use

The products are only used in total hip arthroplasty or semi hip arthroplasty
operated by professional orthopedic surgeon;
JUST products should only be implanted by JUST specific instrumentation;
Check carefully the product name, model, specification and expiry date of
sterilization prior to surgery;
The surgeon is to be thoroughly familiar with the surgical technique,
implants and instruments provided by JUST prior to performing surgery;
Strict aseptic manipulation should be performed when taking the aseptic
products out of package. The outer protective package should be opened by
circulating surgical assistant, the middle package also could be opened by
circulating surgical assistant. Whereas, the inner primary package should be
opened only operator around the operating table;
Implants are disposable and should not be reused.

Procedures for Operation

Femoral head removal: expose the femoral neck, mark the osteotomy line
1-1.5cm superior to lesser trochanter, cut with powered oscillating saw at
about 40 degrees(ignore this procedure for patients with femoral neck
fracture), removal the head with femoral head extractor.
Acetabulum preparation: attach the smallest acetabular reamer to the
acetabular reamer bar, ream the acetabulum vertically to the bottom.
Then continue to ream the acetabulum in 45 degrees of abduction and 15
degrees of anteversion by increasingly larger reamers till bleeding
cancellous bone is exposed. Determine the size of acetabular component
with acetabular trial.
Implantation of acetabular cup and liner: attach the acetabular cup to the
impactor, implant it into position in 45 degrees of abduction and 15
degrees of anteversion. Mind the 3 screw holes on the acetabular
component, if additional fixation is required, drill with flexible drill and put

the screws in position with universal screwdriver. Insert liner of right size
into the cup (mind the direction of anti-dislocation lip).
Femoral canal preparation: Coronal plane of injured side can be
determined by pinching the lateral and medial border of patella, the
opener should be anteverted 15 degrees from the coronal plane. Open the
canal with opener, ensure neutral alignment with medullary canal reamer.
Begin the rasping sequence with the smallest rasp, progress to the next
rasp size until the desired fit and stability is achieved.
Insertion of femoral stem: after extracting the rasp, apply the stem
impactor to the implant of same size as the last rasp and begin to tap the
handle with a mallet.
Attachment of the femoral head: select the proper head to reduce the hip.
Prepare the medullary canal with medullary reamers and broaches,
attention should be paid to avoid fracture. Curettes would be
recommended for osteoporosis patients.
Insert the plug into the distal femoral canal with plug insertion tools, pay
attention to the depth.
Inject the cement into the femoral canal.
Implant the femoral stem with stem impactor . Take off the impactor
after cement solidifies. Put the suitable femoral head onto stem, punch
lightly, then reduce the hip. Assemble the suitable bipolar head or
monopolar head onto stem, punch lightly then reduce the joint (in hemi
hip arthroplasty).
Strict aseptic manipulation should be performed when taking the aseptic
products out of package. The outer protective packaging and the middle
layer plastic tape (box) should be opened by circulating surgical assistant,
but the initial vacuum packing must be opened by the operator around the
operating table.

Sterilization and sterilization validity

Product is sterilized by 60 Co irradiation sterilization. The sterilized product is
indicated by the red sterilization symbol on the label. Sterilization validity is 5
years.
Treatment for sterilization failure
Resterilization accords with the regulations approved by the National Health
Service. All metal components could be resterilized with 60 Co irradiation or dry
heat sterilization; however, the UNWMPE components cannot be resterilized with
60 Co irradiation or dry heat sterilization except Ethylene oxide sterilization.
Instrumentation
Instruments should be sterilized prior to surgery, by hospital according to the
regulations approved by the National Health Service.

Storage
Well packaged products should be kept in a place where is in normal temperature
and relative humidity is no more than 80%, well ventilated, no corrosive gas, cool
and clean. Prevent from extrusion and collision.