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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, shoulder, semi-constrained, metal/polymer cemented
Product CodeKWS
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 7
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSION ORTHOPEDIC
  SUBSTANTIALLY EQUIVALENT 2
ASCENSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEVELAND CLINIC
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY LNC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 6
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 7
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 2
INGEN ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 8
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 5
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 7
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 10
TORNIER, SAS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER CAS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
  1.  K142403  Anatomical Shoulder System/Anatomical Shoulder Dom ...
  2.  K160085  Anatomical Shoulder System, Anatomical Shoulder Do ...
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1066 1066
2015 1169 1169
2016 970 970
2017 1680 1680
2018 1531 1531
2019 1725 1725
2020 1567 1567
2021 1363 1363
2022 1270 1370
2023 1730 1739
2024 773 773

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4249 4295
Device Dislodged or Dislocated 2362 2407
Insufficient Information 1746 1746
Fracture 1145 1160
Appropriate Term/Code Not Available 1043 1043
Unstable 680 716
Break 657 668
Loose or Intermittent Connection 520 520
Loosening of Implant Not Related to Bone-Ingrowth 485 487
Detachment of Device or Device Component 341 341
Naturally Worn 298 298
Loss of Osseointegration 274 274
Migration or Expulsion of Device 231 231
Device Operates Differently Than Expected 227 227
Migration 216 229
Difficult to Insert 201 201
Device Slipped 197 197
Loss of or Failure to Bond 161 161
Osseointegration Problem 160 170
Malposition of Device 126 126
Inadequacy of Device Shape and/or Size 96 96
Detachment Of Device Component 89 89
Disassembly 87 87
Material Separation 80 80
Unintended Movement 79 79
Noise, Audible 71 71
Patient Device Interaction Problem 66 66
Mechanical Problem 62 62
Fitting Problem 58 58
Torn Material 54 54
Positioning Problem 53 53
Material Integrity Problem 50 50
Material Erosion 44 44
Positioning Failure 42 42
Improper or Incorrect Procedure or Method 41 41
Material Fragmentation 39 39
Failure To Adhere Or Bond 38 38
Mechanical Jam 38 38
Use of Device Problem 37 37
Material Twisted/Bent 36 36
Device-Device Incompatibility 35 35
Difficult to Remove 35 35
Therapeutic or Diagnostic Output Failure 34 34
Patient-Device Incompatibility 33 33
Bent 33 33
Missing Value Reason 30 30
Failure to Osseointegrate 29 29
Material Deformation 28 28
Component Missing 27 27
Degraded 26 26
Crack 25 25
Device Contaminated During Manufacture or Shipping 24 24
Difficult To Position 21 21
Device Difficult to Setup or Prepare 21 21
Metal Shedding Debris 20 20
Packaging Problem 20 20
No Apparent Adverse Event 19 19
Contamination 18 18
Device Damaged by Another Device 17 17
Defective Device 17 17
Scratched Material 16 16
Inaccurate Information 16 16
Disconnection 15 15
Failure to Align 14 14
Dull, Blunt 14 14
Connection Problem 13 13
Human-Device Interface Problem 13 13
Entrapment of Device 13 13
Component Falling 13 13
Unintended System Motion 13 13
Microbial Contamination of Device 12 12
Device Issue 11 11
Off-Label Use 11 11
Device Inoperable 11 11
Corroded 10 10
Biocompatibility 10 10
Sticking 9 9
Material Split, Cut or Torn 9 9
Physical Resistance/Sticking 8 8
Defective Component 8 8
Delivered as Unsterile Product 8 8
Material Disintegration 8 8
Tear, Rip or Hole in Device Packaging 8 8
Nonstandard Device 7 7
Device Abrasion From Instrument Or Another Object 6 6
Unsealed Device Packaging 6 6
Material Too Rigid or Stiff 6 6
Contamination /Decontamination Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Mechanics Altered 6 6
Output Problem 6 6
Separation Problem 6 6
Component or Accessory Incompatibility 5 5
Incomplete or Missing Packaging 5 5
Material Rupture 5 5
Difficult or Delayed Positioning 5 5
Component Incompatible 4 4
Misassembled 4 4
Device Appears to Trigger Rejection 4 4
Unintended Collision 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2516 2516
Unspecified Infection 2324 2348
Pain 2191 2191
Joint Dislocation 1488 1525
Failure of Implant 1132 1139
No Information 976 976
No Clinical Signs, Symptoms or Conditions 766 766
Patient Problem/Medical Problem 695 695
Insufficient Information 683 730
No Known Impact Or Consequence To Patient 632 632
Bone Fracture(s) 566 576
Loss of Range of Motion 498 503
Fall 431 431
Joint Laxity 413 435
Implant Pain 368 374
Inadequate Osseointegration 302 312
Injury 278 278
No Consequences Or Impact To Patient 267 267
Not Applicable 252 252
Limited Mobility Of The Implanted Joint 213 213
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 187 187
Osteolysis 182 182
Tissue Damage 155 155
Discomfort 142 142
Bacterial Infection 141 141
Limb Fracture 138 138
Hematoma 109 109
Erosion 107 107
Ossification 94 94
Foreign Body In Patient 92 92
Joint Disorder 78 78
Swelling 73 73
Muscle/Tendon Damage 73 79
Muscle Weakness 65 65
Muscular Rigidity 57 57
Nerve Damage 56 56
Numbness 56 56
Device Embedded In Tissue or Plaque 56 56
Osteopenia/ Osteoporosis 54 54
Metal Related Pathology 54 54
Ambulation Difficulties 50 50
Foreign Body Reaction 49 49
Reaction 45 45
Subluxation 44 44
Hypersensitivity/Allergic reaction 40 40
Inflammation 39 39
Death 38 38
Arthritis 35 35
Unspecified Tissue Injury 34 34
Synovitis 32 32
Rash 31 31
Tingling 31 31
Fracture, Arm 31 31
Post Operative Wound Infection 28 28
Fever 28 28
Weakness 27 27
Fluid Discharge 27 27
No Patient Involvement 26 26
Scar Tissue 26 26
Impaired Healing 26 26
Complaint, Ill-Defined 24 24
Pulmonary Embolism 24 24
Swelling/ Edema 24 24
Adhesion(s) 23 23
Toxicity 23 23
Non-union Bone Fracture 23 23
Rupture 19 19
Laceration(s) 18 18
Erythema 17 17
Wound Dehiscence 16 16
Damage to Ligament(s) 15 15
Sepsis 15 15
Arthralgia 15 15
Excessive Tear Production 14 14
Paralysis 14 14
Hemorrhage/Bleeding 13 13
Cyst(s) 13 13
Seroma 11 11
Sleep Dysfunction 11 11
Test Result 11 11
Abscess 10 10
Pneumonia 9 9
Tissue Breakdown 9 9
Peripheral Nervous Injury 8 8
Unspecified Musculoskeletal problem 8 8
Staphylococcus Aureus 8 8
Thrombus 8 8
Urinary Tract Infection 8 8
Neurological Deficit/Dysfunction 8 8
Myocardial Infarction 8 8
Necrosis 7 7
Neuropathy 7 7
Rheumatoid Arthritis 7 7
Stroke/CVA 7 7
Tachycardia 7 7
Blood Loss 7 7
Bone Shedding Debris 6 6
Thrombosis 6 6
Neck Stiffness 6 6
Debris, Bone Shedding 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II Apr-03-2020
3 Biomet, Inc. II Feb-24-2015
4 Biomet, Inc. II Jan-09-2013
5 Biomet, Inc. II Jun-09-2011
6 Biomet, Inc. II Dec-16-2010
7 DePuy Orthopaedics, Inc. II Mar-01-2018
8 DePuy Orthopaedics, Inc. II Feb-27-2018
9 Depuy Orthopaedics, Inc. II Jan-15-2009
10 Encore Medical, LP II Nov-08-2023
11 Encore Medical, LP II Sep-19-2023
12 Encore Medical, LP II Aug-23-2021
13 Encore Medical, LP II Oct-16-2020
14 Encore Medical, Lp II Mar-28-2018
15 Encore Medical, Lp II Jul-06-2011
16 Encore Medical, Lp II Dec-22-2010
17 Exactech, Inc. II Mar-29-2024
18 Exactech, Inc. II Jan-18-2024
19 Exactech, Inc. II Nov-17-2020
20 Exactech, Inc. II Jan-18-2018
21 Exactech, Inc. II Apr-20-2015
22 Exactech, Inc. II Jul-31-2012
23 Integra LifeSciences Corp. II Nov-08-2014
24 Limacorporate S.p.A II May-25-2016
25 Materialise N.V. II Aug-26-2020
26 Medacta Usa Inc II Jan-03-2020
27 Smith & Nephew Inc II Apr-07-2010
28 Smith & Nephew Inc II Feb-03-2009
29 Stryker Howmedica Osteonics Corp. II Aug-10-2015
30 Stryker Howmedica Osteonics Corp. II Jan-26-2009
31 Tornier, Inc II Jun-28-2023
32 Tornier, Inc II Jul-12-2021
33 Tornier, Inc II Dec-03-2016
34 Tournier, Inc. II Jan-23-2009
35 Zimmer Biomet, Inc. II Nov-22-2019
36 Zimmer Biomet, Inc. II Mar-01-2019
37 Zimmer Biomet, Inc. II Jun-01-2017
38 Zimmer Biomet, Inc. II Mar-27-2017
39 Zimmer Gmbh II Jun-16-2016
40 Zimmer, Inc. II Nov-06-2012
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