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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 2
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 146
Adverse Event Without Identified Device or Use Problem 79
Fracture 33
Migration or Expulsion of Device 26
Break 24
Appropriate Term/Code Not Available 15
Failure To Adhere Or Bond 14
Naturally Worn 13
Loosening of Implant Not Related to Bone-Ingrowth 12
Unstable 11
Difficult to Insert 8
Loose or Intermittent Connection 7
Migration 7
Device Dislodged or Dislocated 7
Malposition of device 6
Degraded 5
Component Missing 4
No Apparent Adverse Event 4
Fitting Problem 4
Device Contamination with Chemical or Other Material 4
Physical Resistance / Sticking 3
Packaging Problem 3
Mechanical Problem 3
Difficult To Position 3
Device Operates Differently Than Expected 3
Patient-Device Incompatibility 2
Material Twisted / Bent 2
Tear, Rip or Hole in Device Packaging 2
Material Integrity Problem 2
Loss of or Failure to Bond 2
Crack 2
Noise, Audible 2
Device Damaged Prior to Use 2
Device-Device Incompatibility 2
Device Contaminated during manufacture or shipping 2
Device Packaging Compromised 2
Mechanical Jam 1
Plate 1
Off-Label Use 1
Device Issue 1
Material Deformation 1
Unintended Movement 1
Loss of Osseointegration 1
Detachment Of Device Component 1
Peeled / Delaminated 1
Inadequacy of Device Shape and/or Size 1
Scratched Material 1
Device Expiration Issue 1
Device Slipped 1
Defective Device 1
Detachment of Device or device Component 1
Delamination 1
Incorrect Measurement 1
Device Abrasion From Instrument Or Another Object 1
Delivered as Unsterile Product 1
Contamination / decontamination Problem 1
Osseointegration Problem 1
Improper or Incorrect Procedure or Method 1
Misconnection 1
Human-Device Interface Problem 1
Total Device Problems 490

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-16-2017
2 Blue Belt Technologies MN II Jun-27-2014
3 Zimmer Biomet, Inc. II Mar-28-2018
4 Zimmer Biomet, Inc. II Mar-14-2018
5 Zimmer Biomet, Inc. II Jan-14-2018
6 Zimmer Biomet, Inc. II Feb-22-2016

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