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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 947 947

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3353 3399
Device Dislodged or Dislocated 1264 1309
Fracture 876 891
Appropriate Term/Code Not Available 770 770
Loosening of Implant Not Related to Bone-Ingrowth 464 466
Break 363 374
Unstable 346 382
Insufficient Information 293 293
Detachment of Device or Device Component 289 289
Migration 194 207
Loss of Osseointegration 186 186
Naturally Worn 180 180
Loose or Intermittent Connection 161 161
Osseointegration Problem 151 161
Difficult to Insert 98 98
Loss of or Failure to Bond 74 74
Unintended Movement 72 72
Patient Device Interaction Problem 66 66
Malposition of Device 60 60
Inadequacy of Device Shape and/or Size 41 41
Positioning Failure 38 38
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
Use of Device Problem 24 24
Failure to Osseointegrate 23 23
Migration or Expulsion of Device 23 23
Positioning Problem 22 22
No Apparent Adverse Event 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
Fitting Problem 14 14
Patient-Device Incompatibility 13 13
Failure to Align 11 11
Defective Device 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
Corroded 9 9
Off-Label Use 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
Delivered as Unsterile Product 6 6
Disconnection 6 6
Output Problem 6 6
Physical Resistance/Sticking 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
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 1442 1466
Joint Dislocation 1073 1110
Pain 1057 1057
No Code Available 979 979
Failure of Implant 870 877
No Clinical Signs, Symptoms or Conditions 790 790
Insufficient Information 714 761
Joint Laxity 424 446
Implant Pain 380 386
Bone Fracture(s) 357 367
Loss of Range of Motion 327 332
No Known Impact Or Consequence To Patient 260 260
Inadequate Osseointegration 258 268
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 141 141
Osteolysis 134 134
Bacterial Infection 121 121
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
Discomfort 83 83
Ossification 81 81
Foreign Body In Patient 79 79
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 44 44
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
Scar Tissue 20 20
Adhesion(s) 20 20
Non-union Bone Fracture 19 19
Arthritis 18 18
No Patient Involvement 17 17
Ambulation Difficulties 16 16
Impaired Healing 16 16
Fracture, Arm 16 16
Toxicity 15 15
Arthralgia 15 15
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
Rheumatoid Arthritis 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
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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