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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, shoulder, hemi-, humeral, metallic uncemented
Regulation Description Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Product CodeHSD
Regulation Number 888.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOCORE9, LLC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 657 657
2021 573 573
2022 508 508
2023 592 592
2024 701 701
2025 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1543 1543
Device Dislodged or Dislocated 410 410
Fracture 209 209
Osseointegration Problem 156 156
Appropriate Term/Code Not Available 133 133
Break 120 120
Difficult to Insert 104 104
Loosening of Implant Not Related to Bone-Ingrowth 73 73
Detachment of Device or Device Component 68 68
Naturally Worn 61 61
Loss of or Failure to Bond 57 57
Patient Device Interaction Problem 56 56
Loss of Osseointegration 45 45
Migration 40 40
Insufficient Information 35 35
Unstable 32 32
Material Deformation 15 15
Use of Device Problem 14 14
Device-Device Incompatibility 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Off-Label Use 12 12
Loose or Intermittent Connection 12 12
Positioning Failure 12 12
Device Damaged Prior to Use 11 11
Tear, Rip or Hole in Device Packaging 10 10
Noise, Audible 10 10
Inaccurate Information 9 9
Malposition of Device 9 9
Crack 9 9
Difficult to Advance 8 8
Material Twisted/Bent 6 6
Packaging Problem 6 6
Material Erosion 6 6
Material Split, Cut or Torn 6 6
Inadequacy of Device Shape and/or Size 5 5
Positioning Problem 5 5
Device Appears to Trigger Rejection 5 5
Therapeutic or Diagnostic Output Failure 5 5
Device Markings/Labelling Problem 5 5
Degraded 5 5
Mechanical Problem 5 5
Failure to Advance 4 4
Component Misassembled 3 3
Patient-Device Incompatibility 3 3
No Apparent Adverse Event 3 3
Fitting Problem 3 3
Connection Problem 3 3
Separation Failure 3 3
Corroded 3 3
Difficult to Remove 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 668 668
Pain 614 614
No Code Available 334 334
Joint Dislocation 323 323
No Clinical Signs, Symptoms or Conditions 310 310
Joint Laxity 249 249
Insufficient Information 219 219
Inadequate Osseointegration 200 200
Failure of Implant 175 175
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 174 174
Unspecified Tissue Injury 174 174
Bone Fracture(s) 142 142
Loss of Range of Motion 133 133
Muscular Rigidity 41 41
Fall 39 39
Hematoma 38 38
No Information 35 35
No Known Impact Or Consequence To Patient 34 34
Osteolysis 33 33
Nerve Damage 32 32
Implant Pain 32 32
Limited Mobility Of The Implanted Joint 31 31
No Consequences Or Impact To Patient 30 30
Discomfort 30 30
Muscle/Tendon Damage 27 27
Foreign Body Reaction 25 25
Ossification 22 22
Inflammation 22 22
Unspecified Musculoskeletal problem 22 22
Adhesion(s) 19 19
Bacterial Infection 16 16
Hypersensitivity/Allergic reaction 15 15
Metal Related Pathology 14 14
Not Applicable 14 14
Pneumonia 14 14
Fatigue 13 13
Erosion 12 12
Injury 12 12
Tissue Damage 12 12
Subluxation 12 12
Sepsis 11 11
Foreign Body In Patient 10 10
Scar Tissue 10 10
Numbness 10 10
Pulmonary Embolism 9 9
Post Operative Wound Infection 8 8
Non-union Bone Fracture 7 7
No Patient Involvement 7 7
Fluid Discharge 7 7
Neuropathy 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jan-22-2021
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