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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 1957
Unstable 410
Adverse Event Without Identified Device or Use Problem 404
Break 348
Fracture 287
Material Integrity Problem 178
Migration or Expulsion of Device 152
Loss of Osseointegration 140
Osseointegration Problem 129
Device Contamination with Chemical or Other Material 121
Mechanical Problem 114
Naturally Worn 106
Packaging Problem 103
Malposition of device 101
Noise, Audible 98
Difficult to Insert 92
Degraded 86
Manufacturing, Packaging or Shipping Problem 84
Device Operates Differently Than Expected 82
Component Missing 66
Appropriate Term/Code Not Available 64
Loose or Intermittent Connection 61
Material Deformation 57
Device Dislodged or Dislocated 55
Detachment of Device or device Component 54
Loosening of Implant Not Related to Bone-Ingrowth 47
Failure To Adhere Or Bond 46
Positioning Problem 46
Scratched Material 45
Migration 42
Fitting Problem 36
Detachment Of Device Component 32
Material Discolored 32
Inadequacy of Device Shape and/or Size 28
Device Slipped 27
Crack 25
Device Packaging Compromised 24
Use of Device Problem 22
Device Damaged Prior to Use 20
Unintended Movement 19
Mechanical Jam 19
Material Distortion 16
Corroded 16
Material Disintegration 14
Tear, Rip or Hole in Device Packaging 13
Connection Problem 13
Residue After Decontamination 12
Difficult To Position 11
Improper or Incorrect Procedure or Method 11
No Apparent Adverse Event 11
Failure to Align 11
Melted 11
Material Erosion 11
Loss of or Failure to Bond 10
Pin 10
Difficult to Remove 9
Clamp 9
Pitted 9
Sticking 8
Material Separation 8
Material Fragmentation 8
Off-Label Use 8
Difficult to Open or Remove Packaging Material 7
Screw 7
Delivered as Unsterile Product 7
Failure to Osseointegrate 7
Disassembly 6
Device Contaminated during manufacture or shipping 6
Device Damaged by Another Device 6
Defective Device 6
Patient-Device Incompatibility 6
Nonstandard device 6
Positioning Failure 6
Shipping Damage or Problem 6
Contamination / decontamination Problem 6
Mechanics Altered 6
Flaked 5
Delamination 5
Defective Component 5
Metal Shedding Debris 5
Device Expiration Issue 4
Compatibility Problem 4
Peeled / Delaminated 4
Contamination During Use 4
Device Difficult to Setup or Prepare 4
Expiration Date Error 3
Activation, Positioning or Separation Problem 3
Handpiece 3
Plate 3
Device Inoperable 3
Disconnection 3
Bent 3
Device Handling Problem 3
Device Disinfection Or Sterilization Issue 3
Torn Material 3
Adhesive 3
Component Misassembled 2
Deformation Due to Compressive Stress 2
Device Abrasion From Instrument Or Another Object 2
Device Reprocessing Problem 2
Total Device Problems 6257

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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