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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
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY LNC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 4
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 4
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 3
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 1680 1680
2018 1532 1532
2019 1726 1726
2020 1567 1567
2021 1363 1363
2022 1083 1183

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2354 2385
Device Dislodged or Dislocated 1509 1552
Insufficient Information 954 954
Appropriate Term/Code Not Available 909 909
Fracture 691 706
Break 392 403
Loosening of Implant Not Related to Bone-Ingrowth 380 382
Unstable 376 408
Loose or Intermittent Connection 312 312
Detachment of Device or Device Component 274 274
Loss of Osseointegration 203 203
Naturally Worn 184 184
Difficult to Insert 181 181
Migration or Expulsion of Device 157 157
Migration 140 153
Loss of or Failure to Bond 98 98
Unintended Movement 73 73
Device Operates Differently Than Expected 71 71
Malposition of Device 58 58
Inadequacy of Device Shape and/or Size 56 56
Noise, Audible 49 49
Osseointegration Problem 46 46
Device Slipped 42 42
Disassembly 41 41
Positioning Failure 40 40
Detachment Of Device Component 39 39
Patient Device Interaction Problem 36 36
Material Erosion 34 34
Material Separation 34 34
Material Fragmentation 33 33
Device-Device Incompatibility 31 31
Positioning Problem 30 30
Therapeutic or Diagnostic Output Failure 29 29
Use of Device Problem 29 29
Patient-Device Incompatibility 26 26
Material Twisted/Bent 24 24
Device Contaminated During Manufacture or Shipping 23 23
Difficult to Remove 23 23
Bent 22 22
Material Integrity Problem 22 22
Missing Value Reason 22 22
Mechanical Problem 21 21
Improper or Incorrect Procedure or Method 21 21
Device Difficult to Setup or Prepare 20 20
Material Deformation 19 19
Difficult To Position 18 18
Fitting Problem 18 18
Failure To Adhere Or Bond 18 18
Component Missing 17 17
Mechanical Jam 17 17
Degraded 16 16
Torn Material 15 15
Contamination 14 14
Unintended System Motion 13 13
Scratched Material 13 13
Packaging Problem 13 13
Inaccurate Information 12 12
Disconnection 12 12
Microbial Contamination of Device 12 12
Failure to Align 11 11
No Apparent Adverse Event 11 11
Corroded 10 10
Crack 10 10
Metal Shedding Debris 9 9
Failure to Osseointegrate 9 9
Dull, Blunt 9 9
Material Split, Cut or Torn 9 9
Defective Device 9 9
Device Damaged by Another Device 8 8
Off-Label Use 8 8
Device Issue 8 8
Delivered as Unsterile Product 8 8
Physical Resistance/Sticking 7 7
Separation Problem 6 6
Contamination /Decontamination Problem 6 6
Connection Problem 6 6
Unsealed Device Packaging 6 6
Material Disintegration 6 6
Tear, Rip or Hole in Device Packaging 6 6
Defective Component 6 6
Entrapment of Device 5 5
Difficult or Delayed Positioning 5 5
Component Falling 5 5
Output Problem 5 5
Biocompatibility 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Difficult to Advance 4 4
Device Contamination with Chemical or Other Material 4 4
Human-Device Interface Problem 4 4
Misassembled 4 4
Device Abrasion From Instrument Or Another Object 4 4
Device Inoperable 4 4
Pitted 4 4
Material Rupture 4 4
Device Appears to Trigger Rejection 4 4
Sticking 4 4
Unexpected Therapeutic Results 3 3
Problem with Sterilization 3 3
Device Packaging Compromised 3 3
Device Operational Issue 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1587 1587
Pain 1549 1549
Unspecified Infection 1437 1456
Joint Dislocation 960 975
Failure of Implant 739 746
No Information 579 579
Insufficient Information 467 514
Patient Problem/Medical Problem 455 455
No Known Impact Or Consequence To Patient 452 452
No Clinical Signs, Symptoms or Conditions 417 417
Loss of Range of Motion 349 354
Bone Fracture(s) 327 327
Not Applicable 253 253
Fall 240 240
Injury 207 207
No Consequences Or Impact To Patient 197 197
Inadequate Osseointegration 185 185
Limited Mobility Of The Implanted Joint 165 165
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 160 160
Tissue Damage 137 137
Implant Pain 131 137
Osteolysis 101 101
Discomfort 100 100
Hematoma 98 98
Joint Laxity 95 96
Bacterial Infection 84 84
Joint Disorder 69 69
Erosion 64 64
Muscle Weakness 62 62
Swelling 62 62
Foreign Body In Patient 60 60
Muscular Rigidity 53 53
Ossification 47 47
Numbness 46 46
Ambulation Difficulties 44 44
Reaction 43 43
Nerve Damage 38 38
Foreign Body Reaction 33 33
Device Embedded In Tissue or Plaque 33 33
Osteopenia/ Osteoporosis 32 32
Tingling 31 31
Metal Related Pathology 30 30
Muscle/Tendon Damage 30 30
Rash 29 29
Weakness 27 27
Synovitis 26 26
Inflammation 26 26
Death 25 25
Arthritis 25 25
Post Operative Wound Infection 25 25
No Patient Involvement 25 25
Fracture, Arm 23 23
Adhesion(s) 20 20
Scar Tissue 18 18
Toxicity 18 18
Unspecified Tissue Injury 18 18
Impaired Healing 17 17
Wound Dehiscence 16 16
Pulmonary Embolism 15 15
Fever 15 15
Erythema 15 15
Fluid Discharge 14 14
Non-union Bone Fracture 13 13
Sepsis 13 13
Paralysis 13 13
Hypersensitivity/Allergic reaction 12 12
Excessive Tear Production 12 12
Sleep Dysfunction 11 11
Rupture 10 10
Damage to Ligament(s) 10 10
Hemorrhage/Bleeding 10 10
Abscess 10 10
Myocardial Infarction 8 8
Pneumonia 8 8
Thrombus 8 8
Arthralgia 7 7
Subluxation 7 7
Necrosis 7 7
Unspecified Musculoskeletal problem 7 7
Muscle Spasm(s) 6 6
Blood Loss 6 6
Thrombosis 6 6
Tissue Breakdown 5 5
Neck Stiffness 5 5
Neurological Deficit/Dysfunction 5 5
Staphylococcus Aureus 5 5
Septic Shock 5 5
Calcium Deposits/Calcification 5 5
Fatigue 5 5
Swelling/ Edema 5 5
Bone Shedding Debris 4 4
Atrial Fibrillation 4 4
Edema 4 4
Debris, Bone Shedding 4 4
Purulent Discharge 4 4
Cardiomyopathy 4 4
Headache 4 4
Limb Fracture 4 4
Twitching 4 4
Hypoesthesia 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 Aug-23-2021
6 Encore Medical, LP II Oct-16-2020
7 Encore Medical, Lp II Mar-28-2018
8 Exactech, Inc. II Nov-17-2020
9 Exactech, Inc. II Jan-18-2018
10 Materialise N.V. II Aug-26-2020
11 Medacta Usa Inc II Jan-03-2020
12 Tornier, Inc II Jul-12-2021
13 Zimmer Biomet, Inc. II Nov-22-2019
14 Zimmer Biomet, Inc. II Mar-01-2019
15 Zimmer Biomet, Inc. II Jun-01-2017
16 Zimmer Biomet, Inc. II Mar-27-2017
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