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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
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Product CodeKWS
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 4
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 3
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 3
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 7
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 970 970
2017 1680 1680
2018 1532 1532
2019 1726 1726
2020 1565 1565
2021 435 435

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1958 1958
Device Dislodged or Dislocated 1336 1336
Insufficient Information 1169 1169
Appropriate Term/Code Not Available 540 540
Fracture 481 481
Unstable 343 343
Loose or Intermittent Connection 306 306
Break 287 287
Loosening of Implant Not Related to Bone-Ingrowth 261 261
Detachment of Device or Device Component 210 210
Migration or Expulsion of Device 184 184
Loss of Osseointegration 182 182
Difficult to Insert 175 175
Naturally Worn 169 169
Loss of or Failure to Bond 106 106
Device Operates Differently Than Expected 93 93
Migration 83 83
Device Slipped 66 66
Unintended Movement 65 65
Detachment Of Device Component 62 62
Disassembly 58 58
Malposition of Device 54 54
Inadequacy of Device Shape and/or Size 51 51
Noise, Audible 45 45
Mechanical Problem 40 40
Osseointegration Problem 40 40
Positioning Problem 36 36
Material Separation 35 35
Positioning Failure 32 32
Device-Device Incompatibility 32 32
Material Erosion 31 31
Fitting Problem 29 29
Use of Device Problem 29 29
Missing Value Reason 29 29
Bent 28 28
Patient-Device Incompatibility 27 27
Improper or Incorrect Procedure or Method 24 24
Failure To Adhere Or Bond 24 24
Material Twisted/Bent 23 23
Mechanical Jam 22 22
Therapeutic or Diagnostic Output Failure 22 22
Device Contaminated During Manufacture or Shipping 22 22
Difficult to Remove 21 21
Difficult To Position 19 19
Material Deformation 19 19
Material Integrity Problem 18 18
Device Difficult to Setup or Prepare 18 18
Torn Material 17 17
Component Missing 16 16
Material Fragmentation 16 16
Contamination 15 15
Device Damaged by Another Device 14 14
Packaging Problem 13 13
Degraded 13 13
Unintended System Motion 13 13
Disconnection 12 12
Microbial Contamination of Device 12 12
Failure to Align 12 12
No Apparent Adverse Event 11 11
Patient Device Interaction Problem 11 11
Scratched Material 11 11
Corroded 10 10
Device Issue 10 10
Metal Shedding Debris 9 9
Defective Device 9 9
Failure to Osseointegrate 8 8
Material Split, Cut or Torn 8 8
Component Falling 7 7
Connection Problem 7 7
Physical Resistance/Sticking 7 7
Dull, Blunt 6 6
Device Inoperable 6 6
Unsealed Device Packaging 6 6
Off-Label Use 5 5
Material Disintegration 5 5
Device Abrasion From Instrument Or Another Object 5 5
Separation Problem 5 5
Tear, Rip or Hole in Device Packaging 5 5
Sticking 5 5
Difficult or Delayed Positioning 5 5
Entrapment of Device 5 5
Delivered as Unsterile Product 4 4
Defective Component 4 4
Difficult to Advance 4 4
Device Contamination with Chemical or Other Material 4 4
Mechanics Altered 4 4
Crack 4 4
Pitted 4 4
Component or Accessory Incompatibility 4 4
Separation Failure 3 3
Physical Resistance 3 3
Device Operational Issue 3 3
Device Packaging Compromised 3 3
Nonstandard Device 3 3
Contamination /Decontamination Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Unexpected Therapeutic Results 3 3
Misassembled 3 3
Material Rupture 3 3
Failure to Advance 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1749 1749
Pain 1540 1540
Unspecified Infection 1241 1241
Joint Dislocation 822 822
No Information 690 690
Patient Problem/Medical Problem 608 608
No Known Impact Or Consequence To Patient 500 500
Failure of Implant 490 490
Bone Fracture(s) 294 294
Loss of Range of Motion 277 277
Injury 254 254
Not Applicable 253 253
No Consequences Or Impact To Patient 236 236
Fall 224 224
Limited Mobility Of The Implanted Joint 184 184
Inadequate Osseointegration 164 164
Tissue Damage 140 140
Insufficient Information 134 134
Discomfort 92 92
Hematoma 89 89
No Clinical Signs, Symptoms or Conditions 86 86
Osteolysis 86 86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 77 77
Joint Disorder 73 73
Swelling 67 67
Bacterial Infection 53 53
Erosion 52 52
Muscular Rigidity 51 51
Muscle Weakness 50 50
Numbness 44 44
Ossification 44 44
Reaction 44 44
Device Embedded In Tissue or Plaque 40 40
Ambulation Difficulties 37 37
Death 36 36
Joint Laxity 33 33
Nerve Damage 32 32
Tingling 31 31
Foreign Body In Patient 31 31
Weakness 30 30
Foreign Body Reaction 29 29
Fracture, Arm 28 28
Rash 27 27
No Patient Involvement 26 26
Synovitis 24 24
Implant Pain 24 24
Arthritis 23 23
Inflammation 18 18
Toxicity 18 18
Impaired Healing 18 18
Osteopenia/ Osteoporosis 17 17
Pulmonary Embolism 17 17
Post Operative Wound Infection 16 16
Adhesion(s) 16 16
Scar Tissue 15 15
Fever 15 15
Wound Dehiscence 14 14
Erythema 13 13
Excessive Tear Production 12 12
Paralysis 12 12
Rupture 11 11
Fluid Discharge 11 11
Sleep Dysfunction 11 11
Hypersensitivity/Allergic reaction 11 11
Hemorrhage/Bleeding 10 10
Damage to Ligament(s) 9 9
Non-union Bone Fracture 9 9
Myocardial Infarction 8 8
Sepsis 8 8
Abscess 8 8
Muscle/Tendon Damage 8 8
Thrombus 8 8
Pneumonia 7 7
Blood Loss 7 7
Necrosis 6 6
Thrombosis 6 6
Muscle Spasm(s) 6 6
Staphylococcus Aureus 5 5
Septic Shock 5 5
Neurological Deficit/Dysfunction 5 5
Calcium Deposits/Calcification 5 5
Neck Stiffness 5 5
Edema 5 5
Debris, Bone Shedding 5 5
Purulent Discharge 4 4
Headache 4 4
Atrial Fibrillation 4 4
Twitching 4 4
Cardiomyopathy 4 4
Fatigue 4 4
Anemia 3 3
Awareness during Anaesthesia 3 3
Neuropathy 3 3
Irritation 3 3
Hypoesthesia 3 3
Arthralgia 3 3
Unspecified Tissue Injury 3 3
Joint Swelling 2 2
Burning Sensation 2 2
Myalgia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II Apr-03-2020
3 DePuy Orthopaedics, Inc. II Mar-01-2018
4 DePuy Orthopaedics, Inc. II Feb-27-2018
5 Encore Medical, LP II Oct-16-2020
6 Encore Medical, Lp II Mar-28-2018
7 Exactech, Inc. II Nov-17-2020
8 Exactech, Inc. II Jan-18-2018
9 Limacorporate S.p.A II May-25-2016
10 Materialise N.V. II Aug-26-2020
11 Medacta Usa Inc II Jan-03-2020
12 Tornier, Inc II Dec-03-2016
13 Zimmer Biomet, Inc. II Nov-22-2019
14 Zimmer Biomet, Inc. II Mar-01-2019
15 Zimmer Biomet, Inc. II Jun-01-2017
16 Zimmer Biomet, Inc. II Mar-27-2017
17 Zimmer Gmbh II Jun-16-2016
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