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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
Product CodeHSD
Regulation Number 888.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARTHROSURFACE INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCORE9, LLC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
FX SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
INGEN ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECRES SPA
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 434 434
2015 574 574
2016 782 782
2017 985 985
2018 647 647
2019 829 829
2020 658 658
2021 570 570
2022 509 509
2023 592 592
2024 154 154

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1856 1856
Insufficient Information 1136 1136
Device Dislodged or Dislocated 1125 1125
Fracture 359 359
Appropriate Term/Code Not Available 333 333
Break 305 305
Loss of Osseointegration 242 242
Loose or Intermittent Connection 152 152
Naturally Worn 143 143
Osseointegration Problem 139 139
Difficult to Insert 123 123
Loss of or Failure to Bond 113 113
Unstable 107 107
Migration or Expulsion of Device 104 104
Detachment of Device or Device Component 85 85
Disassembly 83 83
Loosening of Implant Not Related to Bone-Ingrowth 82 82
Malposition of Device 58 58
Failure To Adhere Or Bond 55 55
Device Slipped 53 53
Device Operates Differently Than Expected 52 52
Migration 45 45
Inadequacy of Device Shape and/or Size 39 39
Patient Device Interaction Problem 38 38
Fitting Problem 35 35
Detachment Of Device Component 32 32
Material Deformation 26 26
Noise, Audible 24 24
Use of Device Problem 24 24
Material Erosion 23 23
Difficult to Remove 20 20
Device-Device Incompatibility 20 20
Positioning Problem 18 18
Material Separation 18 18
Torn Material 17 17
Packaging Problem 16 16
Metal Shedding Debris 16 16
Off-Label Use 15 15
Mechanical Jam 15 15
Patient-Device Incompatibility 14 14
Mechanical Problem 13 13
Connection Problem 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Component Missing 12 12
Tear, Rip or Hole in Device Packaging 11 11
Failure to Osseointegrate 11 11
Crack 11 11
Device Markings/Labelling Problem 10 10
Inaccurate Information 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Contamination with Chemical or Other Material 8 8
Misconnection 8 8
Defective Component 8 8
Failure to Advance 8 8
Nonstandard Device 7 7
Difficult to Advance 7 7
Material Twisted/Bent 6 6
Material Split, Cut or Torn 6 6
Positioning Failure 6 6
Bent 6 6
Device Damaged Prior to Use 6 6
Improper or Incorrect Procedure or Method 6 6
Material Rupture 5 5
Unintended System Motion 5 5
Separation Problem 5 5
Unintended Movement 5 5
Compatibility Problem 5 5
Separation Failure 5 5
Device Contaminated During Manufacture or Shipping 4 4
Entrapment of Device 4 4
Material Fragmentation 4 4
Corroded 4 4
Difficult or Delayed Positioning 4 4
Material Too Rigid or Stiff 4 4
Microbial Contamination of Device 4 4
Dull, Blunt 4 4
Device Appears to Trigger Rejection 3 3
Device Inoperable 3 3
Degraded 3 3
Misassembled 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Scratched Material 3 3
No Apparent Adverse Event 2 2
Device Handling Problem 2 2
Physical Resistance/Sticking 2 2
Component Misassembled 2 2
Output Problem 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 2 2
Device Abrasion From Instrument Or Another Object 2 2
Decoupling 2 2
Material Disintegration 2 2
Component Incompatible 2 2
Sticking 2 2
Unexpected Therapeutic Results 2 2
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Incomplete or Missing Packaging 1 1
Solder Joint Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1479 1479
No Code Available 1414 1414
Unspecified Infection 1219 1219
No Information 979 979
Joint Dislocation 629 629
Bone Fracture(s) 263 263
No Clinical Signs, Symptoms or Conditions 258 258
Inadequate Osseointegration 239 239
Loss of Range of Motion 232 232
No Known Impact Or Consequence To Patient 219 219
Not Applicable 219 219
Joint Laxity 194 194
No Consequences Or Impact To Patient 179 179
Failure of Implant 175 175
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 174 174
Insufficient Information 150 150
Unspecified Tissue Injury 128 128
Fall 108 108
Limited Mobility Of The Implanted Joint 105 105
Hematoma 85 85
Injury 77 77
Discomfort 76 76
Osteolysis 73 73
Joint Disorder 70 70
Tissue Damage 65 65
Muscular Rigidity 47 47
Nerve Damage 47 47
Foreign Body Reaction 43 43
Erosion 40 40
Patient Problem/Medical Problem 35 35
Device Embedded In Tissue or Plaque 34 34
Ossification 33 33
Inflammation 33 33
Death 32 32
Impaired Healing 26 26
Implant Pain 24 24
Muscle/Tendon Damage 23 23
Unspecified Musculoskeletal problem 22 22
Swelling 21 21
Synovitis 21 21
Adhesion(s) 20 20
Numbness 20 20
Foreign Body In Patient 19 19
Bacterial Infection 19 19
Stroke/CVA 19 19
Pneumonia 17 17
Reaction 16 16
Weakness 15 15
Hypersensitivity/Allergic reaction 15 15
Fatigue 13 13
Rupture 13 13
Sepsis 12 12
Post Operative Wound Infection 12 12
No Patient Involvement 12 12
Subluxation 12 12
Edema 12 12
Scar Tissue 12 12
Muscle Weakness 11 11
Arthritis 11 11
Pulmonary Embolism 11 11
Fluid Discharge 11 11
Fracture, Arm 10 10
Osteopenia/ Osteoporosis 9 9
Ambulation Difficulties 8 8
Metal Related Pathology 8 8
Toxicity 8 8
Complaint, Ill-Defined 7 7
Thrombosis 7 7
Pocket Erosion 6 6
Cyst(s) 6 6
Staphylococcus Aureus 6 6
Non-union Bone Fracture 6 6
Swelling/ Edema 6 6
Test Result 5 5
Seroma 5 5
Tingling 5 5
Cellulitis 5 5
Wound Dehiscence 5 5
Neurological Deficit/Dysfunction 5 5
Damage to Ligament(s) 5 5
Necrosis 4 4
Abscess 4 4
Embolus 4 4
Erythema 4 4
Disability 4 4
Arthralgia 4 4
Inadequate Pain Relief 4 4
Muscle Hypotonia 4 4
Thrombosis/Thrombus 4 4
Limb Fracture 3 3
Paresthesia 3 3
Unspecified Mental, Emotional or Behavioural Problem 3 3
Twitching 3 3
Excessive Tear Production 3 3
Debris, Bone Shedding 3 3
Laceration(s) 3 3
Pulmonary Edema 3 3
Nausea 2 2
Undesired Nerve Stimulation 2 2
Calcium Deposits/Calcification 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Arthrosurface, Inc. II Feb-12-2015
2 Ascension Orthopedics, Inc III Feb-02-2019
3 DePuy Orthopaedics, Inc. II Mar-01-2018
4 Exactech, Inc. II Jan-22-2021
5 Fx Solutions II Jul-17-2018
6 Limacorporate S.p.A II Sep-02-2015
7 Stryker Howmedica Osteonics Corp. II Jan-26-2009
8 Synvasive Technology Inc II Apr-17-2013
9 Zimmer Biomet, Inc. II Mar-13-2018
10 Zimmer Inc. II Nov-12-2009
11 Zimmer, Inc. II Jul-10-2013
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