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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Regulation Description Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Product CodeMBH
Regulation Number 888.3565
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 3
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Insufficient Information 1862
Adverse Event Without Identified Device or Use Problem 370
Unstable 324
Break 310
Fracture 276
Material Integrity Problem 178
Migration or Expulsion of Device 151
Loss of Osseointegration 140
Device Contamination with Chemical or Other Material 111
Mechanical Problem 111
Packaging Problem 102
Naturally Worn 96
Malposition of device 96
Noise, Audible 91
Difficult to Insert 85
Manufacturing, Packaging or Shipping Problem 84
Device Operates Differently Than Expected 82
Degraded 81
Osseointegration Problem 79
Appropriate Term/Code Not Available 64
Component Missing 63
Loose or Intermittent Connection 58
Material Deformation 57
Detachment of Device or device Component 51
Positioning Problem 46
Device Dislodged or Dislocated 46
Failure To Adhere Or Bond 46
Scratched Material 45
Fitting Problem 36
Loosening of Implant Not Related to Bone-Ingrowth 36
Migration 36
Material Discolored 32
Detachment Of Device Component 32
Device Slipped 27
Device Packaging Compromised 24
Crack 23
Inadequacy of Device Shape and/or Size 22
Use of Device Problem 22
Device Damaged Prior to Use 20
Mechanical Jam 19
Material Distortion 16
Corroded 16
Unintended Movement 15
Material Disintegration 14
Tear, Rip or Hole in Device Packaging 13
Connection Problem 13
Residue After Decontamination 12
Melted 11
No Apparent Adverse Event 11
Improper or Incorrect Procedure or Method 11
Difficult To Position 11
Failure to Align 11
Material Erosion 10
Pin 10
Pitted 9
Difficult to Remove 9
Loss of or Failure to Bond 9
Clamp 9
Material Fragmentation 8
Off-Label Use 8
Sticking 8
Difficult to Open or Remove Packaging Material 7
Screw 7
Delivered as Unsterile Product 7
Failure to Osseointegrate 7
Contamination / decontamination Problem 6
Disassembly 6
Shipping Damage or Problem 6
Nonstandard device 6
Mechanics Altered 6
Device Damaged by Another Device 6
Material Separation 6
Device Contaminated during manufacture or shipping 5
Flaked 5
Defective Device 5
Delamination 5
Metal Shedding Debris 5
Patient-Device Incompatibility 5
Defective Component 5
Compatibility Problem 4
Contamination During Use 4
Device Difficult to Setup or Prepare 4
Device Expiration Issue 4
Peeled / Delaminated 4
Adhesive 3
Plate 3
Device Handling Problem 3
Torn Material 3
Disconnection 3
Device Disinfection Or Sterilization Issue 3
Activation, Positioning or Separation Problem 3
Device Inoperable 3
Handpiece 3
Expiration Date Error 3
Bent 3
Device Reprocessing Problem 2
Device Operational Issue 2
Device Appears to Trigger Rejection 2
Difficult to Open or Close 2
Deformation Due to Compressive Stress 2
Total Device Problems 5836

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-25-2016
2 DePuy Orthopaedics, Inc. II Jul-20-2015
3 Howmedica Osteonics Corp. II Apr-24-2018
4 Howmedica Osteonics Corp. II Apr-20-2018
5 MicroPort Orthopedics Inc. I Sep-08-2016
6 Smith & Nephew, Inc. II Oct-22-2018
7 Smith & Nephew, Inc. II Jun-11-2018
8 Smith & Nephew, Inc. II May-21-2018
9 Stryker Howmedica Osteonics Corp. II Sep-13-2016
10 Stryker Howmedica Osteonics Corp. II Aug-11-2016
11 Stryker Howmedica Osteonics Corp. II Aug-14-2015
12 Stryker Howmedica Osteonics Corp. II Mar-16-2015
13 Zimmer Biomet, Inc. II Mar-14-2018
14 Zimmer Biomet, Inc. II Mar-14-2018
15 Zimmer Biomet, Inc. II Apr-25-2017
16 Zimmer Biomet, Inc. II Jun-07-2016
17 Zimmer Biomet, Inc. II Feb-22-2016
18 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
19 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
20 Zimmer, Inc. II Mar-12-2015

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