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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 LLC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  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
2016 445 445
2017 558 558
2018 481 481
2019 421 421
2020 216 216
2021 140 140

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 630 630
Device Dislodged or Dislocated 428 428
Insufficient Information 285 285
Fracture 190 190
Loose or Intermittent Connection 175 175
Appropriate Term/Code Not Available 134 134
Break 116 116
Loosening of Implant Not Related to Bone-Ingrowth 113 113
Unstable 94 94
Migration or Expulsion of Device 65 65
Device Slipped 61 61
Naturally Worn 56 56
Detachment of Device or Device Component 54 54
Migration 42 42
Detachment Of Device Component 40 40
Device Operates Differently Than Expected 34 34
Failure To Adhere Or Bond 26 26
Improper or Incorrect Procedure or Method 24 24
Mechanical Jam 24 24
Material Separation 20 20
Difficult to Insert 18 18
Patient-Device Incompatibility 17 17
Loss of or Failure to Bond 15 15
Malposition of Device 14 14
Physical Resistance/Sticking 14 14
Loss of Osseointegration 13 13
Difficult to Remove 13 13
Microbial Contamination of Device 12 12
Contamination 11 11
Positioning Problem 11 11
Material Erosion 10 10
Disassembly 10 10
Unintended Movement 9 9
Material Deformation 8 8
Mechanical Problem 8 8
Component Missing 8 8
Material Fragmentation 7 7
Entrapment of Device 7 7
Dull, Blunt 6 6
Material Split, Cut or Torn 6 6
Noise, Audible 6 6
Patient Device Interaction Problem 5 5
Use of Device Problem 5 5
Separation Failure 5 5
Inadequacy of Device Shape and/or Size 5 5
Sticking 5 5
Component Falling 5 5
Disconnection 4 4
Therapeutic or Diagnostic Output Failure 4 4
Misassembly by Users 4 4
No Apparent Adverse Event 3 3
Difficult or Delayed Separation 3 3
Torn Material 3 3
Human-Device Interface Problem 3 3
Material Protrusion/Extrusion 3 3
Metal Shedding Debris 3 3
Difficult To Position 3 3
Bent 3 3
Failure to Advance 3 3
Peeled/Delaminated 3 3
Fitting Problem 3 3
Device-Device Incompatibility 3 3
Device Contamination with Chemical or Other Material 2 2
Biocompatibility 2 2
Connection Problem 2 2
Device Contamination With Biological Material 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Disconnect 2 2
Unintended System Motion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Degraded 2 2
Positioning Failure 2 2
Material Disintegration 2 2
Material Twisted/Bent 2 2
Defective Device 2 2
Device Operational Issue 2 2
Physical Property Issue 2 2
Inaccurate Information 2 2
Protective Measures Problem 1 1
Temperature Problem 1 1
Device Damaged by Another Device 1 1
Failure to Align 1 1
Output Problem 1 1
Packaging Problem 1 1
Pitted 1 1
Retraction Problem 1 1
Material Integrity Problem 1 1
Scratched Material 1 1
Osseointegration Problem 1 1
Device Fell 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Material Frayed 1 1
Device Alarm System 1 1
Device Damaged Prior to Use 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 468 468
Pain 337 339
Unspecified Infection 330 330
Joint Dislocation 263 263
Joint Disorder 242 242
No Known Impact Or Consequence To Patient 230 230
Failure of Implant 229 229
No Information 172 172
Fall 137 137
Bone Fracture(s) 91 91
Bacterial Infection 72 72
Loss of Range of Motion 55 55
No Consequences Or Impact To Patient 52 52
Limited Mobility Of The Implanted Joint 39 39
Tissue Damage 29 29
Osteolysis 28 28
Injury 26 26
Device Embedded In Tissue or Plaque 26 26
Foreign Body In Patient 23 23
Insufficient Information 22 22
Hematoma 15 15
Discomfort 15 15
Impaired Healing 12 12
Reaction 12 12
Nerve Damage 12 12
Patient Problem/Medical Problem 12 12
No Clinical Signs, Symptoms or Conditions 12 12
Inadequate Osseointegration 11 11
Necrosis 11 11
Death 11 11
Post Operative Wound Infection 10 10
Swelling 10 10
Not Applicable 9 9
Tingling 8 8
Ossification 8 8
Wound Dehiscence 8 8
Erosion 7 7
Sleep Dysfunction 7 7
Pneumonia 7 7
Ambulation Difficulties 6 6
Numbness 6 6
Fracture, Arm 6 6
Erythema 6 6
Cyst(s) 5 5
Irritation 5 5
Fluid Discharge 5 5
Weakness 5 5
No Patient Involvement 5 5
Distress 4 4
Complaint, Ill-Defined 4 4
Pneumothorax 4 4
Myocardial Infarction 4 4
Chest Pain 4 4
Inflammation 4 4
Neck Pain 4 4
Osteopenia/ Osteoporosis 4 4
Toxicity 3 3
Perforation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Shaking/Tremors 3 3
Blood Loss 3 3
Urinary Retention 3 3
Synovitis 3 3
Non-union Bone Fracture 3 3
Tissue Breakdown 2 2
Joint Laxity 2 2
Implant Pain 2 2
Swelling/ Edema 2 2
Burning Sensation 2 2
Arthralgia 2 2
Cellulitis 2 2
Local Reaction 2 2
Muscle/Tendon Damage 2 2
Fever 2 2
Anemia 2 2
Excessive Tear Production 2 2
Deformity/ Disfigurement 1 1
Perforation of Vessels 1 1
Discharge 1 1
Decreased Sensitivity 1 1
Calcium Deposits/Calcification 1 1
Increased Sensitivity 1 1
Hypersensitivity/Allergic reaction 1 1
Metal Related Pathology 1 1
Muscular Rigidity 1 1
Debris, Bone Shedding 1 1
Purulent Discharge 1 1
Foreign Body Reaction 1 1
Foreign Body Sensation in Eye 1 1
Weight Changes 1 1
Subluxation 1 1
Test Result 1 1
Disability 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-23-2018
2 Exactech, Inc. II Oct-03-2018
3 Exactech, Inc. II Dec-22-2016
4 Zimmer Biomet, Inc. II Nov-07-2019
5 Zimmer Biomet, Inc. II Dec-29-2017
6 Zimmer Biomet, Inc. II Sep-22-2017
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