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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 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Insufficient Information 1974
Unstable 430
Adverse Event Without Identified Device or Use Problem 425
Break 360
Fracture 284
Material Integrity Problem 162
Loss of Osseointegration 150
Migration or Expulsion of Device 148
Osseointegration Problem 135
Device Contamination with Chemical or Other Material 121
Mechanical Problem 113
Naturally Worn 113
Malposition of device 107
Packaging Problem 103
Noise, Audible 102
Degraded 87
Manufacturing, Packaging or Shipping Problem 83
Device Operates Differently Than Expected 80
Difficult to Insert 74
Component Missing 66
Appropriate Term/Code Not Available 60
Loose or Intermittent Connection 59
Detachment of Device or device Component 55
Material Deformation 55
Device Dislodged or Dislocated 52
Loosening of Implant Not Related to Bone-Ingrowth 47
Positioning Problem 46
Scratched Material 46
Migration 46
Failure To Adhere Or Bond 35
Material Discolored 32
Inadequacy of Device Shape and/or Size 31
Fitting Problem 29
Detachment Of Device Component 28
Crack 25
Device Slipped 24
Device Packaging Compromised 24
Use of Device Problem 23
Unintended Movement 19
Device Damaged Prior to Use 19
Mechanical Jam 18
Material Distortion 16
Corroded 16
Material Erosion 14
Tear, Rip or Hole in Device Packaging 13
Improper or Incorrect Procedure or Method 13
Connection Problem 13
Residue After Decontamination 12
Difficult To Position 11
Failure to Align 11
Melted 11
Material Disintegration 11
Loss of or Failure to Bond 10
No Apparent Adverse Event 10
Pin 10
Difficult to Remove 9
Clamp 9
Pitted 9
Failure to Osseointegrate 8
Sticking 8
Material Separation 8
Positioning Failure 8
Material Fragmentation 8
Difficult to Open or Remove Packaging Material 7
Contamination / decontamination Problem 7
Delivered as Unsterile Product 7
Device Contaminated during manufacture or shipping 7
Device Damaged by Another Device 6
Defective Device 6
Device Difficult to Setup or Prepare 6
Shipping Damage or Problem 6
Mechanics Altered 6
Nonstandard device 6
Patient-Device Incompatibility 6
Off-Label Use 6
Delamination 5
Defective Component 5
Flaked 5
Metal Shedding Debris 5
Disassembly 5
Compatibility Problem 4
Peeled / Delaminated 4
Screw 4
Device Expiration Issue 4
Contamination During Use 4
Disconnection 3
Expiration Date Error 3
Activation, Positioning or Separation Problem 3
Device Inoperable 3
Device Disinfection Or Sterilization Issue 3
Torn Material 3
Adhesive 3
Bent 3
Device Handling Problem 3
Component or Accessory Incompatibility 2
Component Falling 2
Material Too Rigid or Stiff 2
Device Appears to Trigger Rejection 2
Component Misassembled 2
Deformation Due to Compressive Stress 2
Total Device Problems 6288

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 Sep-27-2019
4 Howmedica Osteonics Corp. II Apr-24-2018
5 Howmedica Osteonics Corp. II Apr-20-2018
6 MicroPort Orthopedics Inc. I Sep-08-2016
7 Smith & Nephew, Inc. II Oct-22-2018
8 Smith & Nephew, Inc. II Jun-11-2018
9 Smith & Nephew, Inc. II May-21-2018
10 Stryker Howmedica Osteonics Corp. II Sep-13-2016
11 Stryker Howmedica Osteonics Corp. II Aug-11-2016
12 Stryker Howmedica Osteonics Corp. II Aug-14-2015
13 Stryker Howmedica Osteonics Corp. II Mar-16-2015
14 Zimmer Biomet, Inc. II Mar-14-2018
15 Zimmer Biomet, Inc. II Mar-14-2018
16 Zimmer Biomet, Inc. II Apr-25-2017
17 Zimmer Biomet, Inc. II Jun-07-2016
18 Zimmer Biomet, Inc. II Feb-22-2016
19 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
20 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
21 Zimmer, Inc. II Mar-12-2015

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