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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Definition 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Product CodeOQI
Regulation Number 888.3353
Device Class 2

Device Problems
No Information 9
Difficult to insert 2
Dislodged or dislocated 2
Foreign material present in device 1
Item contaminated during manufacturing or shipping 1
Unintended movement 1
Not Applicable 1
Migration of device or device component 1
Slippage of device or device component 1
Improper or incorrect procedure or method 1
Device operates differently than expected 1
No code available 1
Total Device Problems 22