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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device shoulder prosthesis, reverse configuration
Definition Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Product CodePHX
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 8
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROSURFACE INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 3
CATALYST ORTHOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 6
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY(IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
FH INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 6
FX SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 7
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYMMETRY MEDICAL MANUFACTURING INC. DBA TECOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 24 24
2018 295 295
2019 504 504
2020 985 985
2021 1413 1413
2022 976 976

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 1337 1337
Device Dislodged or Dislocated 1097 1097
Adverse Event Without Identified Device or Use Problem 813 813
Break 258 258
Fracture 237 237
Unstable 223 223
Loose or Intermittent Connection 170 170
Loosening of Implant Not Related to Bone-Ingrowth 141 141
Detachment of Device or Device Component 121 121
Osseointegration Problem 79 79
Insufficient Information 69 69
Naturally Worn 49 49
Difficult to Insert 47 47
Positioning Problem 29 29
Malposition of Device 28 28
Inadequacy of Device Shape and/or Size 23 23
Device Slipped 21 21
Material Separation 21 21
Migration 21 21
Improper or Incorrect Procedure or Method 16 16
Patient-Device Incompatibility 15 15
Noise, Audible 15 15
Migration or Expulsion of Device 14 14
Therapeutic or Diagnostic Output Failure 13 13
Material Deformation 12 12
Material Integrity Problem 11 11
Loss of Osseointegration 11 11
Material Erosion 11 11
Unintended Movement 11 11
Patient Device Interaction Problem 10 10
Difficult to Remove 10 10
Microbial Contamination of Device 10 10
Off-Label Use 9 9
Positioning Failure 9 9
Difficult to Advance 9 9
Output Problem 9 9
Degraded 8 8
Separation Failure 8 8
Device Operates Differently Than Expected 8 8
Material Fragmentation 7 7
Corroded 7 7
Loss of or Failure to Bond 7 7
Use of Device Problem 7 7
Material Twisted/Bent 6 6
Mechanical Jam 5 5
Mechanical Problem 5 5
Device-Device Incompatibility 5 5
Defective Device 4 4
Device Damaged Prior to Use 4 4
Crack 4 4
Bent 3 3
Disconnection 3 3
Device Appears to Trigger Rejection 3 3
Dull, Blunt 3 3
Material Protrusion/Extrusion 3 3
Scratched Material 3 3
Difficult or Delayed Separation 3 3
Physical Resistance/Sticking 2 2
Mechanics Altered 2 2
Packaging Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Inadequate User Interface 2 2
Compatibility Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Markings/Labelling Problem 2 2
Component Missing 2 2
Labelling, Instructions for Use or Training Problem 2 2
Contamination 2 2
Material Frayed 2 2
Entrapment of Device 2 2
Failure To Adhere Or Bond 2 2
Detachment Of Device Component 2 2
Computer Software Problem 1 1
Signal Artifact/Noise 1 1
Material Disintegration 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Material Rupture 1 1
Problem with Sterilization 1 1
Unexpected Therapeutic Results 1 1
Unraveled Material 1 1
Residue After Decontamination 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Component 1 1
Fitting Problem 1 1
Failure to Align 1 1
Failure to Advance 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Activation, Positioning or SeparationProblem 1 1
Device Operational Issue 1 1
Device Contamination With Biological Material 1 1
Excessive Cooling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 738 738
Insufficient Information 559 559
Joint Dislocation 557 557
Pain 454 455
No Code Available 438 438
Failure of Implant 415 415
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 296 296
No Known Impact Or Consequence To Patient 249 249
No Clinical Signs, Symptoms or Conditions 162 162
Fall 156 156
Joint Laxity 111 111
No Information 82 82
Inadequate Osseointegration 82 82
Bone Fracture(s) 81 81
Loss of Range of Motion 75 75
Hematoma 40 40
Foreign Body In Patient 38 38
Limited Mobility Of The Implanted Joint 30 30
Unspecified Tissue Injury 29 29
Device Embedded In Tissue or Plaque 22 22
Bacterial Infection 22 22
Discomfort 21 21
No Consequences Or Impact To Patient 19 19
Erosion 19 19
Osteopenia/ Osteoporosis 18 18
Metal Related Pathology 18 18
Pulmonary Embolism 17 17
Anemia 16 16
Foreign Body Reaction 16 16
Nerve Damage 16 16
Joint Disorder 16 16
Impaired Healing 15 15
Sepsis 13 13
Swelling 13 14
Injury 12 12
Ossification 12 12
Muscular Rigidity 10 10
Scar Tissue 10 10
Toxicity 9 9
Osteolysis 9 9
Numbness 9 9
Inflammation 9 9
Abdominal Pain 9 9
Wound Dehiscence 8 8
Pneumonia 8 8
Skin Discoloration 8 8
Muscle/Tendon Damage 8 8
Thrombosis/Thrombus 8 8
Urinary Tract Infection 7 7
Neuropathy 7 7
Fever 7 7
Adhesion(s) 7 7
Fatigue 6 6
Reaction 6 6
Patient Problem/Medical Problem 6 6
Subluxation 6 6
Swelling/ Edema 6 6
Unspecified Mental, Emotional or Behavioural Problem 5 5
Tissue Breakdown 5 5
Sweating 5 5
Weakness 5 5
Tissue Damage 5 5
Hypersensitivity/Allergic reaction 5 5
Muscle Weakness 5 5
Rash 4 4
Arthritis 4 4
Synovitis 4 5
Fluid Discharge 4 4
Unspecified Musculoskeletal problem 4 4
Implant Pain 3 3
Fracture, Arm 3 3
Non-union Bone Fracture 3 3
Ambulation Difficulties 3 3
No Patient Involvement 3 3
Erythema 3 3
Stroke/CVA 2 2
Rheumatoid Arthritis 2 2
Atrial Fibrillation 2 2
Post Operative Wound Infection 2 2
Seroma 2 2
Skin Infection 2 2
Bone Shedding Debris 1 1
Localized Skin Lesion 1 1
Limb Fracture 1 1
Malunion of Bone 1 1
Not Applicable 1 1
Test Result 1 1
Shock 1 1
Rupture 1 1
Discharge 1 1
Obstruction/Occlusion 1 1
Alteration In Body Temperature 1 1
Abrasion 1 1
Death 1 1
Edema 1 1
Calcium Deposits/Calcification 1 1
Paralysis 1 1
Impotence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Feb-17-2021
2 Biomet, Inc. II Oct-09-2020
3 Biomet, Inc. II Jun-09-2020
4 Biomet, Inc. II May-28-2020
5 Biomet, Inc. II Apr-20-2020
6 Biomet, Inc. II Mar-31-2020
7 DePuy Orthopaedics, Inc. II Jan-11-2022
8 Encore Medical, LP II Sep-25-2020
9 Encore Medical, Lp II Mar-05-2018
10 Exactech, Inc. II Jun-29-2021
11 Exactech, Inc. II Oct-29-2020
12 Exactech, Inc. II Sep-25-2020
13 Exactech, Inc. II Jan-28-2020
14 Exactech, Inc. II Feb-26-2019
15 Tornier, Inc II Nov-14-2019
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