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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 1362 1362
2022 1270 1370
2023 1728 1737
2024 568 568

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3175 3213
Device Dislodged or Dislocated 1209 1254
Fracture 821 836
Appropriate Term/Code Not Available 769 769
Loosening of Implant Not Related to Bone-Ingrowth 438 440
Break 348 359
Unstable 306 338
Insufficient Information 287 287
Detachment of Device or Device Component 286 286
Migration 192 205
Loss of Osseointegration 180 180
Naturally Worn 174 174
Loose or Intermittent Connection 161 161
Osseointegration Problem 132 132
Difficult to Insert 94 94
Loss of or Failure to Bond 72 72
Unintended Movement 72 72
Patient Device Interaction Problem 63 63
Malposition of Device 55 55
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 27 27
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
Mechanical Problem 15 15
Device Difficult to Setup or Prepare 14 14
No Apparent Adverse Event 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
Biocompatibility 10 10
Defective Device 9 9
Corroded 9 9
Off-Label Use 9 9
Material Deformation 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
Fitting Problem 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
Improper or Incorrect Procedure or Method 4 4
Defective Component 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
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
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1364 1388
Pain 1033 1033
Joint Dislocation 998 1015
No Code Available 979 979
Failure of Implant 806 813
No Clinical Signs, Symptoms or Conditions 743 743
Insufficient Information 673 720
Joint Laxity 390 391
Implant Pain 359 365
Bone Fracture(s) 339 341
Loss of Range of Motion 318 323
No Known Impact Or Consequence To Patient 260 260
Inadequate Osseointegration 239 239
No Information 229 229
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 187 187
Fall 184 184
Patient Problem/Medical Problem 165 165
Injury 165 165
Osteolysis 134 134
Limb Fracture 130 130
Bacterial Infection 116 116
No Consequences Or Impact To Patient 106 106
Not Applicable 91 91
Hematoma 87 87
Limited Mobility Of The Implanted Joint 83 83
Erosion 82 82
Discomfort 78 78
Foreign Body In Patient 77 77
Ossification 77 77
Tissue Damage 64 64
Muscle/Tendon Damage 61 61
Metal Related Pathology 54 54
Osteopenia/ Osteoporosis 49 49
Muscular Rigidity 47 47
Muscle Weakness 45 45
Subluxation 38 38
Swelling 36 36
Unspecified Tissue Injury 34 34
Numbness 31 31
Hypersensitivity/Allergic reaction 28 28
Inflammation 28 28
Nerve Damage 26 26
Reaction 25 25
Fluid Discharge 24 24
Post Operative Wound Infection 22 22
Device Embedded In Tissue or Plaque 22 22
Foreign Body Reaction 22 22
Fever 21 21
Joint Disorder 21 21
Adhesion(s) 20 20
Scar Tissue 19 19
Non-union Bone Fracture 19 19
Swelling/ Edema 19 19
Synovitis 18 18
Arthritis 18 18
No Patient Involvement 17 17
Fracture, Arm 16 16
Impaired Healing 16 16
Toxicity 15 15
Arthralgia 14 14
Ambulation Difficulties 14 14
Pulmonary Embolism 14 14
Wound Dehiscence 14 14
Erythema 13 13
Hemorrhage/Bleeding 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
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
Peripheral Nervous Injury 6 6
Bone Shedding Debris 6 6
Aspiration Pneumonitis 5 5
Respiratory Failure 5 5
Loss of consciousness 5 5
Calcium Deposits/Calcification 5 5
Abscess 5 5
Fatigue 5 5
Neurological Deficit/Dysfunction 5 5
Hypoxia 5 5
Memory Loss/Impairment 4 4
Paralysis 4 4
Fungal Infection 4 4
Blood Loss 4 4
Multiple Fractures 3 3
Perforation 3 3
Myocardial Infarction 3 3
Granuloma 3 3
Atrial Fibrillation 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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