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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
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY LNC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 3
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 5
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 4
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 970 970
2017 1680 1680
2018 1532 1532
2019 1726 1726
2020 1566 1566
2021 1055 1055

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2113 2113
Device Dislodged or Dislocated 1447 1447
Insufficient Information 1185 1185
Appropriate Term/Code Not Available 717 717
Fracture 545 545
Unstable 361 361
Loose or Intermittent Connection 325 325
Break 310 310
Loosening of Implant Not Related to Bone-Ingrowth 301 301
Detachment of Device or Device Component 233 233
Loss of Osseointegration 189 189
Migration or Expulsion of Device 187 187
Difficult to Insert 181 181
Naturally Worn 174 174
Loss of or Failure to Bond 110 110
Migration 99 99
Device Operates Differently Than Expected 93 93
Unintended Movement 67 67
Device Slipped 66 66
Detachment Of Device Component 62 62
Disassembly 58 58
Inadequacy of Device Shape and/or Size 56 56
Malposition of Device 56 56
Noise, Audible 51 51
Mechanical Problem 44 44
Osseointegration Problem 43 43
Material Separation 42 42
Positioning Problem 38 38
Positioning Failure 35 35
Material Erosion 33 33
Device-Device Incompatibility 32 32
Use of Device Problem 31 31
Fitting Problem 29 29
Missing Value Reason 29 29
Patient-Device Incompatibility 28 28
Bent 28 28
Improper or Incorrect Procedure or Method 25 25
Therapeutic or Diagnostic Output Failure 25 25
Material Twisted/Bent 25 25
Failure To Adhere Or Bond 24 24
Difficult to Remove 23 23
Mechanical Jam 22 22
Device Contaminated During Manufacture or Shipping 22 22
Material Deformation 20 20
Material Fragmentation 20 20
Difficult To Position 19 19
Device Difficult to Setup or Prepare 18 18
Material Integrity Problem 18 18
Torn Material 17 17
Component Missing 16 16
Contamination 15 15
Degraded 14 14
Patient Device Interaction Problem 14 14
Device Damaged by Another Device 14 14
Packaging Problem 13 13
Unintended System Motion 13 13
Disconnection 12 12
Failure to Align 12 12
Microbial Contamination of Device 12 12
Scratched Material 11 11
No Apparent Adverse Event 11 11
Defective Device 10 10
Device Issue 10 10
Corroded 10 10
Metal Shedding Debris 9 9
Material Split, Cut or Torn 9 9
Physical Resistance/Sticking 8 8
Failure to Osseointegrate 8 8
Component Falling 7 7
Dull, Blunt 7 7
Connection Problem 7 7
Separation Problem 6 6
Unsealed Device Packaging 6 6
Off-Label Use 6 6
Device Inoperable 6 6
Sticking 5 5
Device Abrasion From Instrument Or Another Object 5 5
Crack 5 5
Difficult or Delayed Positioning 5 5
Material Disintegration 5 5
Entrapment of Device 5 5
Tear, Rip or Hole in Device Packaging 5 5
Difficult to Advance 4 4
Device Contamination with Chemical or Other Material 4 4
Mechanics Altered 4 4
Component or Accessory Incompatibility 4 4
Material Rupture 4 4
Pitted 4 4
Delivered as Unsterile Product 4 4
Defective Component 4 4
Unexpected Therapeutic Results 3 3
Misassembled 3 3
Nonstandard Device 3 3
Device Packaging Compromised 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Separation Failure 3 3
Physical Resistance 3 3
Contamination /Decontamination Problem 3 3
Device Operational Issue 3 3
Material Distortion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1749 1749
Pain 1610 1610
Unspecified Infection 1356 1356
Joint Dislocation 893 893
No Information 691 691
Patient Problem/Medical Problem 608 608
Failure of Implant 597 597
No Known Impact Or Consequence To Patient 500 500
Bone Fracture(s) 317 317
Loss of Range of Motion 305 305
Injury 254 254
Not Applicable 253 253
Fall 244 244
Insufficient Information 243 243
No Consequences Or Impact To Patient 236 236
Limited Mobility Of The Implanted Joint 184 184
Inadequate Osseointegration 174 174
No Clinical Signs, Symptoms or Conditions 155 155
Tissue Damage 140 140
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 129 129
Discomfort 95 95
Osteolysis 93 93
Hematoma 90 90
Joint Disorder 73 73
Swelling 67 67
Bacterial Infection 56 56
Erosion 56 56
Muscle Weakness 54 54
Muscular Rigidity 51 51
Ossification 45 45
Numbness 45 45
Reaction 44 44
Joint Laxity 43 43
Device Embedded In Tissue or Plaque 42 42
Ambulation Difficulties 41 41
Death 36 36
Foreign Body In Patient 35 35
Nerve Damage 32 32
Tingling 31 31
Weakness 30 30
Foreign Body Reaction 30 30
Fracture, Arm 28 28
Rash 27 27
No Patient Involvement 26 26
Inflammation 25 25
Implant Pain 25 25
Synovitis 24 24
Arthritis 24 24
Osteopenia/ Osteoporosis 23 23
Muscle/Tendon Damage 19 19
Toxicity 18 18
Impaired Healing 18 18
Post Operative Wound Infection 17 17
Pulmonary Embolism 17 17
Scar Tissue 17 17
Adhesion(s) 16 16
Fever 15 15
Wound Dehiscence 14 14
Erythema 13 13
Excessive Tear Production 13 13
Fluid Discharge 12 12
Paralysis 12 12
Hypersensitivity/Allergic reaction 12 12
Sleep Dysfunction 11 11
Rupture 11 11
Hemorrhage/Bleeding 10 10
Damage to Ligament(s) 9 9
Sepsis 9 9
Non-union Bone Fracture 9 9
Thrombus 8 8
Unspecified Tissue Injury 8 8
Myocardial Infarction 8 8
Abscess 8 8
Necrosis 7 7
Pneumonia 7 7
Blood Loss 7 7
Thrombosis 6 6
Muscle Spasm(s) 6 6
Neurological Deficit/Dysfunction 5 5
Septic Shock 5 5
Staphylococcus Aureus 5 5
Calcium Deposits/Calcification 5 5
Fatigue 5 5
Edema 5 5
Debris, Bone Shedding 5 5
Neck Stiffness 5 5
Bone Shedding Debris 4 4
Twitching 4 4
Purulent Discharge 4 4
Cardiomyopathy 4 4
Atrial Fibrillation 4 4
Headache 4 4
Irritation 3 3
Neuropathy 3 3
Anemia 3 3
Awareness during Anaesthesia 3 3
Hypoesthesia 3 3
Arthralgia 3 3
Tissue Breakdown 3 3
Disc Impingement 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 Aug-23-2021
6 Encore Medical, LP II Oct-16-2020
7 Encore Medical, Lp II Mar-28-2018
8 Exactech, Inc. II Nov-17-2020
9 Exactech, Inc. II Jan-18-2018
10 Limacorporate S.p.A II May-25-2016
11 Materialise N.V. II Aug-26-2020
12 Medacta Usa Inc II Jan-03-2020
13 Tornier, Inc II Jul-12-2021
14 Tornier, Inc II Dec-03-2016
15 Zimmer Biomet, Inc. II Nov-22-2019
16 Zimmer Biomet, Inc. II Mar-01-2019
17 Zimmer Biomet, Inc. II Jun-01-2017
18 Zimmer Biomet, Inc. II Mar-27-2017
19 Zimmer Gmbh II Jun-16-2016
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