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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 4
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 4
TECHMAH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 2
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 1531 1531
2019 1724 1724
2020 1567 1567
2021 1362 1362
2022 1268 1368
2023 1086 1095

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2750 2788
Device Dislodged or Dislocated 1337 1382
Appropriate Term/Code Not Available 835 835
Fracture 779 794
Insufficient Information 602 602
Loosening of Implant Not Related to Bone-Ingrowth 428 430
Break 370 381
Unstable 290 322
Detachment of Device or Device Component 290 290
Loose or Intermittent Connection 238 238
Loss of Osseointegration 201 201
Naturally Worn 196 196
Migration 187 200
Difficult to Insert 131 131
Osseointegration Problem 103 103
Migration or Expulsion of Device 88 88
Loss of or Failure to Bond 82 82
Unintended Movement 73 73
Malposition of Device 65 65
Patient Device Interaction Problem 55 55
Noise, Audible 44 44
Inadequacy of Device Shape and/or Size 43 43
Positioning Failure 40 40
Material Fragmentation 34 34
Material Erosion 32 32
Therapeutic or Diagnostic Output Failure 29 29
Positioning Problem 28 28
Material Separation 27 27
Use of Device Problem 26 26
Device Slipped 25 25
Material Twisted/Bent 24 24
Mechanical Jam 24 24
Device-Device Incompatibility 24 24
Device Contaminated During Manufacture or Shipping 23 23
Difficult to Remove 23 23
Material Integrity Problem 21 21
Device Operates Differently Than Expected 21 21
Device Difficult to Setup or Prepare 20 20
Component Missing 18 18
Mechanical Problem 18 18
Patient-Device Incompatibility 16 16
Degraded 15 15
Inaccurate Information 15 15
No Apparent Adverse Event 14 14
Material Deformation 14 14
Disassembly 14 14
Detachment Of Device Component 14 14
Crack 14 14
Unintended System Motion 13 13
Defective Device 13 13
Failure to Osseointegrate 12 12
Packaging Problem 12 12
Dull, Blunt 11 11
Failure to Align 11 11
Microbial Contamination of Device 10 10
Disconnection 10 10
Corroded 10 10
Off-Label Use 9 9
Scratched Material 9 9
Material Split, Cut or Torn 9 9
Difficult To Position 8 8
Improper or Incorrect Procedure or Method 8 8
Fitting Problem 8 8
Physical Resistance/Sticking 7 7
Separation Problem 6 6
Output Problem 6 6
Contamination /Decontamination Problem 6 6
Delivered as Unsterile Product 6 6
Defective Component 6 6
Tear, Rip or Hole in Device Packaging 6 6
Entrapment of Device 6 6
Unsealed Device Packaging 5 5
Difficult or Delayed Positioning 5 5
Failure To Adhere Or Bond 5 5
Device Issue 5 5
Biocompatibility 5 5
Device Damaged by Another Device 5 5
Difficult to Advance 4 4
Connection Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Rupture 4 4
Device Appears to Trigger Rejection 4 4
Contamination 4 4
Material Disintegration 4 4
Bent 3 3
Misassembled 3 3
Problem with Sterilization 3 3
Metal Shedding Debris 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Human-Device Interface Problem 3 3
Installation-Related Problem 2 2
Device Packaging Compromised 2 2
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Mechanics Altered 2 2
Device Fell 2 2
Ejection Problem 2 2
Device Handling Problem 2 2
Failure to Advance 2 2
Unexpected Therapeutic Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1407 1431
Pain 1339 1339
No Code Available 1223 1223
Joint Dislocation 1019 1036
Failure of Implant 773 780
No Clinical Signs, Symptoms or Conditions 582 582
Insufficient Information 563 610
No Information 380 380
Bone Fracture(s) 362 364
Loss of Range of Motion 357 362
No Known Impact Or Consequence To Patient 342 342
Patient Problem/Medical Problem 305 305
Not Applicable 252 252
Implant Pain 233 239
Inadequate Osseointegration 226 226
Joint Laxity 217 218
Fall 203 203
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 187 187
Injury 184 184
No Consequences Or Impact To Patient 158 158
Osteolysis 136 136
Limited Mobility Of The Implanted Joint 115 115
Bacterial Infection 106 106
Hematoma 100 100
Discomfort 94 94
Tissue Damage 94 94
Erosion 83 83
Foreign Body In Patient 71 71
Swelling 60 60
Muscle Weakness 57 57
Muscular Rigidity 50 50
Metal Related Pathology 50 50
Muscle/Tendon Damage 50 50
Joint Disorder 47 47
Ambulation Difficulties 44 44
Osteopenia/ Osteoporosis 43 43
Ossification 43 43
Reaction 39 39
Numbness 39 39
Nerve Damage 34 34
Limb Fracture 32 32
Inflammation 31 31
Hypersensitivity/Allergic reaction 30 30
Rash 29 29
Foreign Body Reaction 27 27
Arthritis 27 27
Unspecified Tissue Injury 27 27
Tingling 25 25
Device Embedded In Tissue or Plaque 24 24
Post Operative Wound Infection 23 23
Fluid Discharge 22 22
Adhesion(s) 22 22
Scar Tissue 20 20
No Patient Involvement 20 20
Fracture, Arm 20 20
Non-union Bone Fracture 20 20
Toxicity 18 18
Synovitis 18 18
Swelling/ Edema 17 17
Fever 16 16
Impaired Healing 16 16
Pulmonary Embolism 15 15
Wound Dehiscence 14 14
Erythema 13 13
Hemorrhage/Bleeding 13 13
Death 12 12
Subluxation 12 12
Cyst(s) 11 11
Sepsis 11 11
Seroma 9 9
Abscess 9 9
Rupture 9 9
Sleep Dysfunction 9 9
Arthralgia 8 8
Damage to Ligament(s) 8 8
Weakness 7 7
Thrombus 7 7
Unspecified Musculoskeletal problem 7 7
Bone Shedding Debris 6 6
Blood Loss 6 6
Pneumonia 6 6
Stroke/CVA 6 6
Fatigue 5 5
Calcium Deposits/Calcification 5 5
Neurological Deficit/Dysfunction 5 5
Septic Shock 5 5
Excessive Tear Production 5 5
Loss of consciousness 5 5
Tissue Breakdown 4 4
Peripheral Nervous Injury 4 4
Paralysis 4 4
Perforation 4 4
Memory Loss/Impairment 4 4
Muscle Spasm(s) 4 4
Atrial Fibrillation 4 4
Debris, Bone Shedding 3 3
Awareness during Anaesthesia 3 3
Myocardial Infarction 3 3
Necrosis 3 3
Irritation 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II Apr-03-2020
3 DePuy Orthopaedics, Inc. II Mar-01-2018
4 DePuy Orthopaedics, Inc. II Feb-27-2018
5 Encore Medical, LP II Sep-19-2023
6 Encore Medical, LP II Aug-23-2021
7 Encore Medical, LP II Oct-16-2020
8 Encore Medical, Lp II Mar-28-2018
9 Exactech, Inc. II Nov-17-2020
10 Exactech, Inc. II Jan-18-2018
11 Materialise N.V. II Aug-26-2020
12 Medacta Usa Inc II Jan-03-2020
13 Tornier, Inc II Jun-28-2023
14 Tornier, Inc II Jul-12-2021
15 Zimmer Biomet, Inc. II Nov-22-2019
16 Zimmer Biomet, Inc. II Mar-01-2019
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