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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 9
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROSURFACE INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOMET CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 10
BIOMET MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 5
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 3
DEPUY FRANCE
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 7
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY(IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DJO GLOBAL
  SUBSTANTIALLY EQUIVALENT 1
DJO SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 10
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 9
FH INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
FIX SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 4
FX SHOULDER USA, INC
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
FX SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
INGEN ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 7
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
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
  SUBSTANTIALLY EQUIVALENT 2
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 6
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 9
TORNIER, SAS
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2015 14 14
2016 5 5
2017 24 24
2018 295 295
2019 504 504
2020 985 985
2021 1405 1405
2022 1341 1341
2023 1416 1416
2024 506 506

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1976 1976
Device Dislodged or Dislocated 1393 1393
Appropriate Term/Code Not Available 1342 1342
Fracture 403 403
Unstable 344 344
Break 318 318
Loosening of Implant Not Related to Bone-Ingrowth 194 194
Detachment of Device or Device Component 177 177
Loose or Intermittent Connection 175 175
Osseointegration Problem 134 134
Difficult to Insert 97 97
Insufficient Information 96 96
Patient Device Interaction Problem 88 88
Naturally Worn 71 71
Migration 47 47
Device-Device Incompatibility 44 44
Malposition of Device 43 43
Microbial Contamination of Device 42 42
Positioning Problem 34 34
Material Deformation 31 31
Loss of Osseointegration 31 31
Inadequacy of Device Shape and/or Size 28 28
Unintended Movement 28 28
Material Separation 24 24
Device Appears to Trigger Rejection 24 24
Improper or Incorrect Procedure or Method 23 23
Noise, Audible 23 23
Device Slipped 22 22
Positioning Failure 22 22
Material Erosion 21 21
No Apparent Adverse Event 19 19
Material Integrity Problem 17 17
Off-Label Use 16 16
Patient-Device Incompatibility 16 16
Defective Device 15 15
Migration or Expulsion of Device 15 15
Mechanical Jam 14 14
Therapeutic or Diagnostic Output Failure 13 13
Biocompatibility 13 13
Difficult to Advance 12 12
Difficult to Remove 11 11
Use of Device Problem 10 10
Output Problem 10 10
Device Operates Differently Than Expected 8 8
Separation Failure 8 8
Mechanical Problem 8 8
Material Fragmentation 8 8
Crack 8 8
Degraded 8 8
Loss of or Failure to Bond 8 8
Corroded 7 7
Unexpected Therapeutic Results 7 7
Physical Resistance/Sticking 7 7
Material Twisted/Bent 6 6
Fitting Problem 5 5
Device Damaged Prior to Use 4 4
Dull, Blunt 4 4
Component Missing 3 3
Structural Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Difficult to Open or Close 3 3
Bent 3 3
Failure To Adhere Or Bond 3 3
Disconnection 3 3
Entrapment of Device 3 3
Scratched Material 3 3
Packaging Problem 3 3
Material Protrusion/Extrusion 3 3
Compatibility Problem 3 3
Difficult or Delayed Separation 3 3
Lack of Effect 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Inadequate User Interface 2 2
Mechanics Altered 2 2
Material Frayed 2 2
Contamination 2 2
Detachment Of Device Component 2 2
Labelling, Instructions for Use or Training Problem 2 2
Unsealed Device Packaging 2 2
Device Difficult to Setup or Prepare 2 2
Environmental Particulates 2 2
Device Markings/Labelling Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Osseointegrate 2 2
Unraveled Material 1 1
Defective Component 1 1
Residue After Decontamination 1 1
Failure to Align 1 1
Failure to Advance 1 1
Device Operational Issue 1 1
Excessive Cooling 1 1
Device Contamination With Biological Material 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Material Rupture 1 1
Problem with Sterilization 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1104 1104
Joint Dislocation 1057 1057
Insufficient Information 710 710
Pain 632 633
Failure of Implant 615 615
No Clinical Signs, Symptoms or Conditions 496 496
No Code Available 441 441
Joint Laxity 368 368
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 311 311
No Known Impact Or Consequence To Patient 251 251
Fall 177 177
Inadequate Osseointegration 151 151
Bone Fracture(s) 150 150
Loss of Range of Motion 125 125
Implant Pain 121 121
No Information 82 82
Foreign Body In Patient 63 63
Subluxation 59 59
Osteolysis 54 54
Osteopenia/ Osteoporosis 50 50
Hematoma 48 48
Metal Related Pathology 43 43
Unspecified Tissue Injury 40 40
Erosion 37 37
Limited Mobility Of The Implanted Joint 30 30
Nerve Damage 28 28
Discomfort 28 28
Bacterial Infection 27 27
Ossification 26 26
Device Embedded In Tissue or Plaque 23 23
Muscle/Tendon Damage 22 22
Swelling/ Edema 19 19
No Consequences Or Impact To Patient 19 19
Pulmonary Embolism 17 17
Anemia 16 16
Hypersensitivity/Allergic reaction 16 16
Foreign Body Reaction 16 16
Joint Disorder 16 16
Impaired Healing 15 15
Sepsis 15 15
Muscular Rigidity 15 15
Limb Fracture 15 15
Scar Tissue 14 14
Rheumatoid Arthritis 14 14
Swelling 13 14
Synovitis 13 14
Injury 13 13
Numbness 11 11
Adhesion(s) 11 11
Inflammation 11 11
Muscle Weakness 10 10
Fever 9 9
Abdominal Pain 9 9
Toxicity 9 9
Post Operative Wound Infection 9 9
Thrombosis/Thrombus 8 8
Skin Discoloration 8 8
Pneumonia 8 8
Wound Dehiscence 8 8
Neuropathy 7 7
Damage to Ligament(s) 7 7
Urinary Tract Infection 7 7
Non-union Bone Fracture 7 7
Arthralgia 6 6
Reaction 6 6
Paralysis 6 6
Rash 6 6
Fatigue 6 6
Unspecified Musculoskeletal problem 6 6
Peripheral Nervous Injury 6 6
Patient Problem/Medical Problem 6 6
Unspecified Mental, Emotional or Behavioural Problem 5 5
Fluid Discharge 5 5
Tissue Breakdown 5 5
Arthritis 5 5
Weakness 5 5
Tissue Damage 5 5
Sweating 5 5
Stroke/CVA 4 4
Extravasation 4 4
Erythema 3 3
Fracture, Arm 3 3
Seroma 3 3
No Patient Involvement 3 3
Ambulation Difficulties 3 3
Muscle Hypotonia 3 3
Skin Infection 2 2
Confusion/ Disorientation 2 2
Dizziness 2 2
Urinary Frequency 2 2
Atrial Fibrillation 2 2
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Cyst(s) 1 1
Death 1 1
Edema 1 1
Abrasion 1 1
Impotence 1 1
Obstruction/Occlusion 1 1
Shock 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 Jan-02-2024
9 Encore Medical, LP II Dec-12-2023
10 Encore Medical, LP II Nov-08-2023
11 Encore Medical, LP II Oct-12-2023
12 Encore Medical, LP II Sep-19-2023
13 Encore Medical, LP II Sep-25-2020
14 Encore Medical, Lp II Mar-05-2018
15 Encore Medical, Lp II Jan-09-2016
16 Encore Medical, Lp II Oct-16-2015
17 Exactech, Inc. II Mar-29-2024
18 Exactech, Inc. II Jun-29-2021
19 Exactech, Inc. II Oct-29-2020
20 Exactech, Inc. II Sep-25-2020
21 Exactech, Inc. II Jan-28-2020
22 Exactech, Inc. II Feb-26-2019
23 FX SHOULDER II Jan-29-2024
24 Tornier, Inc II Jan-19-2024
25 Tornier, Inc II Oct-13-2023
26 Tornier, Inc II Nov-14-2019
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