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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, shoulder, non-constrained, metal/polymer cemented
Regulation Description Shoulder joint metal/polymer non-constrained cemented prosthesis.
Product CodeKWT
Regulation Number 888.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
CATALYST ORTHOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS INC
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 558 558
2018 481 481
2019 421 421
2020 216 216
2021 227 227

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 610 610
Device Dislodged or Dislocated 370 370
Insufficient Information 185 185
Fracture 151 151
Loose or Intermittent Connection 144 144
Appropriate Term/Code Not Available 130 130
Loosening of Implant Not Related to Bone-Ingrowth 124 124
Break 94 94
Unstable 88 88
Detachment of Device or Device Component 59 59
Naturally Worn 50 50
Migration or Expulsion of Device 48 48
Migration 42 42
Device Slipped 36 36
Detachment Of Device Component 35 35
Device Operates Differently Than Expected 21 21
Patient-Device Incompatibility 17 17
Difficult to Insert 17 17
Mechanical Jam 14 14
Physical Resistance/Sticking 14 14
Improper or Incorrect Procedure or Method 13 13
Loss of Osseointegration 13 13
Difficult to Remove 13 13
Material Separation 12 12
Failure To Adhere Or Bond 12 12
Microbial Contamination of Device 12 12
Malposition of Device 11 11
Contamination 11 11
Loss of or Failure to Bond 10 10
Material Erosion 9 9
Disassembly 9 9
Positioning Problem 8 8
Patient Device Interaction Problem 7 7
Unintended Movement 7 7
Entrapment of Device 7 7
Material Fragmentation 7 7
Mechanical Problem 7 7
Component Missing 7 7
Noise, Audible 6 6
Material Split, Cut or Torn 6 6
Separation Failure 5 5
Sticking 5 5
Inadequacy of Device Shape and/or Size 4 4
Disconnection 4 4
Dull, Blunt 4 4
Material Deformation 4 4
Misassembly by Users 4 4
Therapeutic or Diagnostic Output Failure 3 3
Difficult or Delayed Separation 3 3
Human-Device Interface Problem 3 3
Fitting Problem 3 3
Failure to Advance 3 3
Bent 3 3
Use of Device Problem 3 3
Peeled/Delaminated 3 3
Difficult To Position 3 3
Unintended System Motion 2 2
Metal Shedding Debris 2 2
Component Falling 2 2
Material Disintegration 2 2
Positioning Failure 2 2
Failure to Disconnect 2 2
Device Contamination With Biological Material 2 2
Biocompatibility 2 2
Connection Problem 2 2
Device-Device Incompatibility 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Inaccurate Information 2 2
Torn Material 2 2
Physical Property Issue 2 2
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Osseointegration Problem 1 1
Output Problem 1 1
Packaging Problem 1 1
Device Fell 1 1
Device Contamination with Chemical or Other Material 1 1
Device Operational Issue 1 1
Device Damaged by Another Device 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Activation, Positioning or SeparationProblem 1 1
Defective Device 1 1
Failure to Align 1 1
Device Damaged Prior to Use 1 1
Material Frayed 1 1
Degraded 1 1
Device Alarm System 1 1
Unexpected Therapeutic Results 1 1
Retraction Problem 1 1
Material Puncture/Hole 1 1
Pitted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 376 376
Pain 295 297
Failure of Implant 278 278
Joint Disorder 237 237
Joint Dislocation 237 237
Unspecified Infection 230 230
No Known Impact Or Consequence To Patient 164 164
No Information 146 146
Fall 102 102
Bacterial Infection 86 86
Bone Fracture(s) 70 70
Loss of Range of Motion 52 52
No Consequences Or Impact To Patient 45 45
Limited Mobility Of The Implanted Joint 35 35
Tissue Damage 27 27
Device Embedded In Tissue or Plaque 26 26
Osteolysis 25 25
Insufficient Information 23 23
Foreign Body In Patient 19 19
Injury 19 19
Hematoma 15 15
No Clinical Signs, Symptoms or Conditions 15 15
Inadequate Osseointegration 13 13
Patient Problem/Medical Problem 12 12
Impaired Healing 12 12
Discomfort 12 12
Nerve Damage 12 12
Necrosis 11 11
Reaction 11 11
Post Operative Wound Infection 10 10
Swelling 10 10
Not Applicable 9 9
Death 8 8
Tingling 8 8
Sleep Dysfunction 7 7
Ossification 7 7
Pneumonia 7 7
Erythema 6 6
Erosion 6 6
Wound Dehiscence 6 6
Ambulation Difficulties 6 6
Numbness 6 6
Fracture, Arm 6 6
Weakness 5 5
Cyst(s) 5 5
Irritation 5 5
No Patient Involvement 5 5
Inflammation 4 4
Myocardial Infarction 4 4
Pneumothorax 4 4
Chest Pain 4 4
Distress 4 4
Neck Pain 4 4
Osteopenia/ Osteoporosis 4 4
Blood Loss 3 3
Shaking/Tremors 3 3
Non-union Bone Fracture 3 3
Toxicity 3 3
Urinary Retention 3 3
Perforation 3 3
Synovitis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Muscle/Tendon Damage 3 3
Implant Pain 2 2
Swelling/ Edema 2 2
Joint Laxity 2 2
Local Reaction 2 2
Cellulitis 2 2
Anemia 2 2
Fever 2 2
Burning Sensation 2 2
Excessive Tear Production 2 2
Tissue Breakdown 2 2
Decreased Sensitivity 1 1
Disability 1 1
Discharge 1 1
Perforation of Vessels 1 1
Complaint, Ill-Defined 1 1
Arthralgia 1 1
Deformity/ Disfigurement 1 1
Foreign Body Reaction 1 1
Foreign Body Sensation in Eye 1 1
Debris, Bone Shedding 1 1
Hypersensitivity/Allergic reaction 1 1
Calcium Deposits/Calcification 1 1
Muscular Rigidity 1 1
Metal Related Pathology 1 1
Subluxation 1 1
Unspecified Musculoskeletal problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-23-2018
2 Exactech, Inc. II Oct-03-2018
3 Zimmer Biomet, Inc. II Nov-07-2019
4 Zimmer Biomet, Inc. II Dec-29-2017
5 Zimmer Biomet, Inc. II Sep-22-2017
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