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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 1731 1740
2024 1145 1145

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3451 3497
Device Dislodged or Dislocated 1300 1345
Fracture 889 904
Appropriate Term/Code Not Available 770 770
Loosening of Implant Not Related to Bone-Ingrowth 473 475
Break 375 386
Unstable 365 401
Insufficient Information 301 301
Detachment of Device or Device Component 291 291
Migration 194 207
Loss of Osseointegration 193 193
Naturally Worn 186 186
Loose or Intermittent Connection 161 161
Osseointegration Problem 157 167
Difficult to Insert 98 98
Loss of or Failure to Bond 75 75
Unintended Movement 73 73
Patient Device Interaction Problem 66 66
Malposition of Device 62 62
Inadequacy of Device Shape and/or Size 41 41
Positioning Failure 39 39
Noise, Audible 35 35
Material Twisted/Bent 31 31
Material Fragmentation 31 31
Therapeutic or Diagnostic Output Failure 29 29
Mechanical Jam 25 25
Use of Device Problem 25 25
Material Erosion 24 24
Migration or Expulsion of Device 23 23
Failure to Osseointegrate 23 23
No Apparent Adverse Event 22 22
Positioning Problem 22 22
Material Integrity Problem 21 21
Device-Device Incompatibility 21 21
Material Separation 21 21
Difficult to Remove 18 18
Crack 17 17
Inaccurate Information 16 16
Mechanical Problem 15 15
Fitting Problem 15 15
Device Difficult to Setup or Prepare 14 14
Off-Label Use 13 13
Patient-Device Incompatibility 13 13
Degraded 12 12
Failure to Align 11 11
Defective Device 11 11
Component Missing 11 11
Device Contaminated During Manufacture or Shipping 11 11
Packaging Problem 11 11
Material Deformation 10 10
Physical Resistance/Sticking 10 10
Biocompatibility 10 10
Corroded 9 9
Scratched Material 9 9
Material Split, Cut or Torn 9 9
Device Damaged by Another Device 8 8
Dull, Blunt 8 8
Tear, Rip or Hole in Device Packaging 6 6
Microbial Contamination of Device 6 6
Device Slipped 6 6
Disconnection 6 6
Delivered as Unsterile Product 6 6
Output Problem 6 6
Difficult or Delayed Positioning 5 5
Contamination /Decontamination Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Defective Component 4 4
Device Appears to Trigger Rejection 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
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
Difficult to Advance 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 Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Difficult or Delayed Separation 1 1
Misassembled During Installation 1 1
Device Fell 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 1484 1508
Joint Dislocation 1127 1164
Pain 1076 1076
No Code Available 979 979
Failure of Implant 902 909
No Clinical Signs, Symptoms or Conditions 811 811
Insufficient Information 734 781
Joint Laxity 450 472
Implant Pain 395 401
Bone Fracture(s) 363 373
Loss of Range of Motion 338 343
Inadequate Osseointegration 271 281
No Known Impact Or Consequence To Patient 260 260
No Information 229 229
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 189 189
Fall 187 187
Patient Problem/Medical Problem 165 165
Injury 165 165
Limb Fracture 148 148
Osteolysis 137 137
Bacterial Infection 122 122
No Consequences Or Impact To Patient 106 106
Erosion 94 94
Not Applicable 91 91
Hematoma 89 89
Discomfort 84 84
Limited Mobility Of The Implanted Joint 83 83
Ossification 82 82
Foreign Body In Patient 79 79
Muscle/Tendon Damage 75 81
Tissue Damage 64 64
Metal Related Pathology 54 54
Osteopenia/ Osteoporosis 52 52
Muscular Rigidity 47 47
Muscle Weakness 45 45
Subluxation 45 45
Swelling 36 36
Unspecified Tissue Injury 36 36
Hypersensitivity/Allergic reaction 34 34
Inflammation 32 32
Numbness 31 31
Nerve Damage 27 27
Fever 26 26
Reaction 25 25
Non-union Bone Fracture 24 24
Fluid Discharge 24 24
Foreign Body Reaction 24 24
Swelling/ Edema 24 24
Synovitis 22 22
Post Operative Wound Infection 22 22
Device Embedded In Tissue or Plaque 22 22
Joint Disorder 21 21
Ambulation Difficulties 20 20
Scar Tissue 20 20
Adhesion(s) 20 20
Arthritis 18 18
No Patient Involvement 17 17
Impaired Healing 16 16
Fracture, Arm 16 16
Arthralgia 15 15
Toxicity 15 15
Pulmonary Embolism 14 14
Wound Dehiscence 14 14
Hemorrhage/Bleeding 14 14
Erythema 13 13
Damage to Ligament(s) 11 11
Sepsis 11 11
Seroma 11 11
Cyst(s) 11 11
Tingling 11 11
Rupture 10 10
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
Rheumatoid Arthritis 6 6
Stroke/CVA 6 6
Weakness 6 6
Bone Shedding Debris 6 6
Localized Skin Lesion 5 5
Loss of consciousness 5 5
Aspiration Pneumonitis 5 5
Respiratory Failure 5 5
Calcium Deposits/Calcification 5 5
Abscess 5 5
Fatigue 5 5
Hypoxia 5 5
Neurological Deficit/Dysfunction 5 5
Paralysis 5 5
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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