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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Product CodeHSX
Regulation Number 888.3520
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 145
Adverse Event Without Identified Device or Use Problem 78
Fracture 35
Break 27
Migration or Expulsion of Device 25
Loosening of Implant Not Related to Bone-Ingrowth 16
Unstable 15
Appropriate Term/Code Not Available 14
Failure To Adhere Or Bond 13
Difficult to Insert 12
Loose or Intermittent Connection 11
Naturally Worn 9
Migration 7
Malposition of device 6
Device Dislodged or Dislocated 6
Device Contamination with Chemical or Other Material 4
No Apparent Adverse Event 4
Degraded 4
Noise, Audible 4
Physical Resistance / Sticking 3
Difficult To Position 3
Component Missing 3
Device Operates Differently Than Expected 3
Mechanical Problem 3
Packaging Problem 3
Material Twisted / Bent 3
Fitting Problem 2
Crack 2
Loss of or Failure to Bond 2
Device Contaminated during manufacture or shipping 2
Device Packaging Compromised 2
Positioning Failure 2
Device-Device Incompatibility 2
Detachment of Device or device Component 1
Scratched Material 1
Osseointegration Problem 1
Device Damaged Prior to Use 1
Off-Label Use 1
Improper or Incorrect Procedure or Method 1
Incomplete or Inadequate Connection 1
Contamination / decontamination Problem 1
Device Abrasion From Instrument Or Another Object 1
Misconnection 1
Mechanical Jam 1
Defective Device 1
Loss of Osseointegration 1
Inadequacy of Device Shape and/or Size 1
Detachment Of Device Component 1
Material Deformation 1
Unintended Movement 1
Incorrect Measurement 1
Material Integrity Problem 1
Peeled / Delaminated 1
Device Issue 1
Total Device Problems 491

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-16-2017
2 Zimmer Biomet, Inc. II Mar-28-2018
3 Zimmer Biomet, Inc. II Mar-14-2018
4 Zimmer Biomet, Inc. II Jan-14-2018
5 Zimmer Biomet, Inc. II Feb-22-2016

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