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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated 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 CodeOQG
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STELKAST
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 27
Dislodged or dislocated 12
No Known Device Problem 10
Material integrity issue 9
Break 8
Fracture 5
Device operates differently than expected 5
Degraded 3
Size incorrect for patient 3
Loose or intermittent connection 2
Mechanical issue 2
Use of Device Issue 2
Component missing 1
Physical resistance 1
Device or device fragments location unknown 1
Item contaminated during manufacturing or shipping 1
Slippage of device or device component 1
Device inoperable 1
Unstable 1
Disconnection 1
Detachment of device component 1
Osseointegration issue 1
Total Device Problems 98

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stelkast Co II Apr-07-2013

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