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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 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY LNC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 3
TECHMAH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 2
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
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 3282 3328
Device Dislodged or Dislocated 1244 1289
Fracture 844 859
Appropriate Term/Code Not Available 770 770
Loosening of Implant Not Related to Bone-Ingrowth 453 455
Break 356 367
Unstable 339 375
Detachment of Device or Device Component 288 288
Insufficient Information 287 287
Migration 192 205
Loss of Osseointegration 186 186
Naturally Worn 179 179
Loose or Intermittent Connection 161 161
Osseointegration Problem 148 158
Difficult to Insert 96 96
Loss of or Failure to Bond 73 73
Unintended Movement 72 72
Patient Device Interaction Problem 63 63
Malposition of Device 58 58
Inadequacy of Device Shape and/or Size 41 41
Positioning Failure 37 37
Noise, Audible 35 35
Material Fragmentation 31 31
Therapeutic or Diagnostic Output Failure 29 29
Material Twisted/Bent 29 29
Mechanical Jam 25 25
Material Erosion 24 24
Migration or Expulsion of Device 23 23
Failure to Osseointegrate 23 23
Positioning Problem 22 22
Use of Device Problem 21 21
Material Separation 21 21
Device-Device Incompatibility 21 21
Material Integrity Problem 20 20
Difficult to Remove 18 18
Crack 17 17
Inaccurate Information 16 16
No Apparent Adverse Event 15 15
Mechanical Problem 15 15
Device Difficult to Setup or Prepare 14 14
Patient-Device Incompatibility 13 13
Failure to Align 11 11
Component Missing 11 11
Degraded 11 11
Packaging Problem 11 11
Device Contaminated During Manufacture or Shipping 11 11
Material Deformation 10 10
Biocompatibility 10 10
Defective Device 10 10
Fitting Problem 9 9
Corroded 9 9
Off-Label Use 9 9
Scratched Material 9 9
Material Split, Cut or Torn 9 9
Dull, Blunt 8 8
Tear, Rip or Hole in Device Packaging 6 6
Microbial Contamination of Device 6 6
Device Slipped 6 6
Delivered as Unsterile Product 6 6
Disconnection 6 6
Output Problem 6 6
Device Damaged by Another Device 5 5
Physical Resistance/Sticking 5 5
Difficult or Delayed Positioning 5 5
Contamination /Decontamination Problem 5 5
Device Appears to Trigger Rejection 4 4
Defective Component 4 4
Improper or Incorrect Procedure or Method 4 4
Unsealed Device Packaging 4 4
Material Rupture 4 4
Entrapment of Device 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Separation Problem 3 3
Misassembled 3 3
Unintended System Motion 3 3
Material Disintegration 3 3
Problem with Sterilization 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Difficult to Advance 2 2
Device Markings/Labelling Problem 2 2
Connection Problem 2 2
Unexpected Therapeutic Results 2 2
Contamination 2 2
Nonstandard Device 2 2
Material Invagination 2 2
Device Contamination with Chemical or Other Material 2 2
Human-Device Interface Problem 2 2
Installation-Related Problem 2 2
Ejection Problem 2 2
Device Fell 1 1
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Difficult or Delayed Separation 1 1
Misassembled During Installation 1 1
Wrong Label 1 1
Incorrect Measurement 1 1
Particulates 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Device Alarm System 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1409 1433
Joint Dislocation 1049 1086
Pain 1040 1040
No Code Available 979 979
Failure of Implant 832 839
No Clinical Signs, Symptoms or Conditions 764 764
Insufficient Information 681 728
Joint Laxity 412 434
Implant Pain 368 374
Bone Fracture(s) 354 364
Loss of Range of Motion 322 327
No Known Impact Or Consequence To Patient 260 260
Inadequate Osseointegration 255 265
No Information 229 229
Fall 187 187
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 187 187
Patient Problem/Medical Problem 165 165
Injury 165 165
Limb Fracture 138 138
Osteolysis 134 134
Bacterial Infection 120 120
No Consequences Or Impact To Patient 106 106
Erosion 94 94
Not Applicable 91 91
Hematoma 87 87
Limited Mobility Of The Implanted Joint 83 83
Ossification 81 81
Discomfort 80 80
Foreign Body In Patient 78 78
Muscle/Tendon Damage 72 78
Tissue Damage 64 64
Metal Related Pathology 54 54
Osteopenia/ Osteoporosis 52 52
Muscular Rigidity 47 47
Muscle Weakness 45 45
Subluxation 43 43
Swelling 36 36
Hypersensitivity/Allergic reaction 34 34
Unspecified Tissue Injury 34 34
Inflammation 32 32
Numbness 31 31
Nerve Damage 26 26
Fever 26 26
Reaction 25 25
Fluid Discharge 24 24
Swelling/ Edema 24 24
Foreign Body Reaction 23 23
Synovitis 22 22
Device Embedded In Tissue or Plaque 22 22
Post Operative Wound Infection 22 22
Joint Disorder 21 21
Adhesion(s) 20 20
Scar Tissue 19 19
Non-union Bone Fracture 19 19
Arthritis 18 18
No Patient Involvement 17 17
Impaired Healing 16 16
Fracture, Arm 16 16
Toxicity 15 15
Arthralgia 14 14
Ambulation Difficulties 14 14
Pulmonary Embolism 14 14
Wound Dehiscence 14 14
Hemorrhage/Bleeding 13 13
Erythema 13 13
Damage to Ligament(s) 11 11
Sepsis 11 11
Seroma 11 11
Cyst(s) 11 11
Tingling 11 11
Rupture 8 8
Tissue Breakdown 8 8
Peripheral Nervous Injury 8 8
Unspecified Musculoskeletal problem 8 8
Urinary Tract Infection 7 7
Pneumonia 7 7
Tachycardia 7 7
Thrombus 7 7
Rash 6 6
Death 6 6
Stroke/CVA 6 6
Weakness 6 6
Bone Shedding Debris 6 6
Localized Skin Lesion 5 5
Respiratory Failure 5 5
Loss of consciousness 5 5
Aspiration Pneumonitis 5 5
Rheumatoid Arthritis 5 5
Calcium Deposits/Calcification 5 5
Abscess 5 5
Fatigue 5 5
Hypoxia 5 5
Neurological Deficit/Dysfunction 5 5
Paralysis 4 4
Laceration(s) 4 4
Memory Loss/Impairment 4 4
Blood Loss 4 4
Fungal Infection 4 4
Multiple Fractures 3 3
Myocardial Infarction 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II Apr-03-2020
3 Encore Medical, LP II Nov-08-2023
4 Encore Medical, LP II Sep-19-2023
5 Encore Medical, LP II Aug-23-2021
6 Encore Medical, LP II Oct-16-2020
7 Exactech, Inc. II Mar-29-2024
8 Exactech, Inc. II Jan-18-2024
9 Exactech, Inc. II Nov-17-2020
10 Materialise N.V. II Aug-26-2020
11 Medacta Usa Inc II Jan-03-2020
12 Tornier, Inc II Jun-28-2023
13 Tornier, Inc II Jul-12-2021
14 Zimmer Biomet, Inc. II Nov-22-2019
15 Zimmer Biomet, Inc. II Mar-01-2019
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