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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 1724 1724
2020 1567 1567
2021 1362 1362
2022 1270 1370
2023 1723 1732
2024 161 161

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2961 2999
Device Dislodged or Dislocated 1165 1210
Fracture 775 790
Appropriate Term/Code Not Available 769 769
Loosening of Implant Not Related to Bone-Ingrowth 429 431
Break 334 345
Insufficient Information 279 279
Detachment of Device or Device Component 278 278
Unstable 251 283
Migration 186 199
Naturally Worn 171 171
Loss of Osseointegration 171 171
Loose or Intermittent Connection 161 161
Osseointegration Problem 121 121
Difficult to Insert 94 94
Loss of or Failure to Bond 72 72
Unintended Movement 72 72
Patient Device Interaction Problem 59 59
Malposition of Device 55 55
Inadequacy of Device Shape and/or Size 37 37
Positioning Failure 37 37
Noise, Audible 35 35
Material Fragmentation 31 31
Therapeutic or Diagnostic Output Failure 29 29
Material Erosion 24 24
Migration or Expulsion of Device 23 23
Material Twisted/Bent 23 23
Mechanical Jam 22 22
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
Inaccurate Information 16 16
Mechanical Problem 15 15
Device Difficult to Setup or Prepare 14 14
Crack 13 13
Patient-Device Incompatibility 13 13
No Apparent Adverse Event 13 13
Failure to Align 11 11
Component Missing 11 11
Degraded 11 11
Packaging Problem 10 10
Device Contaminated During Manufacture or Shipping 10 10
Material Deformation 9 9
Scratched Material 9 9
Material Split, Cut or Torn 9 9
Corroded 9 9
Off-Label Use 9 9
Defective Device 9 9
Dull, Blunt 8 8
Failure to Osseointegrate 8 8
Device Slipped 6 6
Microbial Contamination of Device 6 6
Fitting Problem 6 6
Biocompatibility 6 6
Delivered as Unsterile Product 6 6
Disconnection 6 6
Output Problem 6 6
Physical Resistance/Sticking 5 5
Difficult or Delayed Positioning 5 5
Contamination /Decontamination Problem 5 5
Tear, Rip or Hole in Device Packaging 5 5
Defective Component 4 4
Device Appears to Trigger Rejection 4 4
Improper or Incorrect Procedure or Method 4 4
Unsealed Device Packaging 4 4
Material Rupture 4 4
Entrapment of Device 4 4
Device Damaged by Another 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
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
Nonstandard Device 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 1262 1286
Pain 1017 1017
No Code Available 979 979
Joint Dislocation 950 967
Failure of Implant 769 776
No Clinical Signs, Symptoms or Conditions 684 684
Insufficient Information 639 686
Joint Laxity 327 328
Implant Pain 324 330
Bone Fracture(s) 323 325
Loss of Range of Motion 311 316
No Known Impact Or Consequence To Patient 260 260
No Information 229 229
Inadequate Osseointegration 220 220
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 187 187
Fall 178 178
Patient Problem/Medical Problem 165 165
Injury 165 165
Osteolysis 129 129
Bacterial Infection 113 113
Limb Fracture 112 112
No Consequences Or Impact To Patient 106 106
Not Applicable 91 91
Hematoma 86 86
Limited Mobility Of The Implanted Joint 83 83
Erosion 81 81
Foreign Body In Patient 74 74
Ossification 73 73
Discomfort 68 68
Tissue Damage 64 64
Muscle/Tendon Damage 55 55
Metal Related Pathology 50 50
Muscular Rigidity 47 47
Muscle Weakness 44 44
Osteopenia/ Osteoporosis 44 44
Swelling 36 36
Unspecified Tissue Injury 32 32
Numbness 30 30
Hypersensitivity/Allergic reaction 28 28
Subluxation 28 28
Inflammation 28 28
Nerve Damage 26 26
Reaction 25 25
Fluid Discharge 23 23
Device Embedded In Tissue or Plaque 22 22
Post Operative Wound Infection 22 22
Foreign Body Reaction 22 22
Joint Disorder 21 21
Adhesion(s) 20 20
Non-union Bone Fracture 19 19
Swelling/ Edema 19 19
Synovitis 18 18
Scar Tissue 18 18
Arthritis 18 18
No Patient Involvement 17 17
Impaired Healing 16 16
Fracture, Arm 16 16
Toxicity 15 15
Wound Dehiscence 14 14
Fever 14 14
Ambulation Difficulties 14 14
Arthralgia 14 14
Pulmonary Embolism 13 13
Erythema 13 13
Hemorrhage/Bleeding 13 13
Damage to Ligament(s) 11 11
Tingling 11 11
Cyst(s) 11 11
Sepsis 11 11
Seroma 9 9
Rupture 8 8
Tissue Breakdown 8 8
Unspecified Musculoskeletal problem 7 7
Thrombus 7 7
Pneumonia 6 6
Weakness 6 6
Peripheral Nervous Injury 6 6
Bone Shedding Debris 6 6
Death 6 6
Stroke/CVA 6 6
Fatigue 5 5
Abscess 5 5
Calcium Deposits/Calcification 5 5
Loss of consciousness 5 5
Neurological Deficit/Dysfunction 5 5
Fungal Infection 4 4
Rash 4 4
Memory Loss/Impairment 4 4
Paralysis 4 4
Blood Loss 4 4
Granuloma 3 3
Atrial Fibrillation 3 3
Multiple Fractures 3 3
Perforation 3 3
Awareness during Anaesthesia 3 3
Myocardial Infarction 3 3
Malunion of Bone 3 3
Ankylosis 2 2
Thrombosis 2 2
Abrasion 2 2

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 Jan-18-2024
8 Exactech, Inc. II Nov-17-2020
9 Materialise N.V. II Aug-26-2020
10 Medacta Usa Inc II Jan-03-2020
11 Tornier, Inc II Jun-28-2023
12 Tornier, Inc II Jul-12-2021
13 Zimmer Biomet, Inc. II Nov-22-2019
14 Zimmer Biomet, Inc. II Mar-01-2019
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