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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
HOWMEDICA OSTEONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Insufficient Information 2059
Unstable 494
Adverse Event Without Identified Device or Use Problem 477
Break 382
Fracture 327
Loss of Osseointegration 183
Material Integrity Problem 162
Migration or Expulsion of Device 149
Osseointegration Problem 137
Device Contamination with Chemical or Other Material 121
Naturally Worn 120
Mechanical Problem 116
Noise, Audible 109
Malposition of device 108
Packaging Problem 105
Degraded 87
Manufacturing, Packaging or Shipping Problem 83
Difficult to Insert 81
Device Operates Differently Than Expected 79
Component Missing 65
Detachment of Device or device Component 63
Appropriate Term/Code Not Available 59
Loose or Intermittent Connection 58
Material Deformation 57
Loosening of Implant Not Related to Bone-Ingrowth 53
Migration 53
Device Dislodged or Dislocated 52
Positioning Problem 47
Scratched Material 47
Failure To Adhere Or Bond 35
Inadequacy of Device Shape and/or Size 33
Material Discolored 32
Fitting Problem 30
Detachment Of Device Component 28
Crack 25
Unintended Movement 24
Use of Device Problem 24
Device Slipped 24
Device Packaging Compromised 24
Device Damaged Prior to Use 19
Material Erosion 18
Mechanical Jam 18
Material Distortion 16
Connection Problem 16
Corroded 16
Failure to Osseointegrate 15
Tear, Rip or Hole in Device Packaging 13
Improper or Incorrect Procedure or Method 13
Positioning Failure 12
Residue After Decontamination 12
Difficult To Position 11
Failure to Align 11
Loss of or Failure to Bond 11
Melted 11
Material Disintegration 11
Material Fragmentation 10
No Apparent Adverse Event 10
Pin 10
Difficult to Remove 9
Patient Device Interaction Problem 9
Clamp 9
Device Contaminated during manufacture or shipping 8
Material Separation 8
Sticking 8
Pitted 8
Delivered as Unsterile Product 7
Device Difficult to Setup or Prepare 7
Contamination / decontamination Problem 7
Off-Label Use 7
Difficult to Open or Remove Packaging Material 7
Patient-Device Incompatibility 6
Shipping Damage or Problem 6
Mechanics Altered 6
Nonstandard device 6
Device Damaged by Another Device 6
Metal Shedding Debris 5
Defective Device 5
Disassembly 5
Flaked 5
Delamination 5
Defective Component 5
Contamination During Use 4
Compatibility Problem 4
Peeled / Delaminated 4
Screw 4
Device Expiration Issue 4
Device Disinfection Or Sterilization Issue 3
Adhesive 3
Torn Material 3
Bent 3
Device Handling Problem 3
Disconnection 3
Activation, Positioning or Separation Problem 3
Expiration Date Error 3
Device Inoperable 3
Plate 2
Difficult to Open or Close 2
Device Operational Issue 2
Handpiece 2
Device Misassembled During Manufacturing / Shipping 2
Total Device Problems 6676

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 Jan-28-2020
8 Smith & Nephew, Inc. II Oct-22-2018
9 Smith & Nephew, Inc. II Jun-11-2018
10 Smith & Nephew, Inc. II May-21-2018
11 Stryker Howmedica Osteonics Corp. II Sep-13-2016
12 Stryker Howmedica Osteonics Corp. II Aug-11-2016
13 Stryker Howmedica Osteonics Corp. II Aug-14-2015
14 Stryker Howmedica Osteonics Corp. II Mar-16-2015
15 Zimmer Biomet, Inc. II Mar-14-2018
16 Zimmer Biomet, Inc. II Mar-14-2018
17 Zimmer Biomet, Inc. II Apr-25-2017
18 Zimmer Biomet, Inc. II Jun-07-2016
19 Zimmer Biomet, Inc. II Feb-22-2016
20 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
21 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
22 Zimmer, Inc. II Mar-12-2015

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