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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/polymer + additive, cemented
Regulation Description Hip joint metal/polymer semi-constrained cemented 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 CodeOQH
Regulation Number 888.3350
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Loose or Intermittent Connection 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 1 1
Joint Dislocation 1 1

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