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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 1410 1410
2022 1341 1341
2023 1416 1416
2024 768 768

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2112 2112
Device Dislodged or Dislocated 1448 1448
Appropriate Term/Code Not Available 1343 1343
Fracture 416 416
Unstable 353 353
Break 322 322
Loosening of Implant Not Related to Bone-Ingrowth 214 214
Detachment of Device or Device Component 182 182
Loose or Intermittent Connection 175 175
Osseointegration Problem 135 135
Difficult to Insert 103 103
Insufficient Information 98 98
Patient Device Interaction Problem 89 89
Naturally Worn 77 77
Migration 51 51
Malposition of Device 44 44
Device-Device Incompatibility 44 44
Microbial Contamination of Device 42 42
Positioning Problem 34 34
Material Deformation 33 33
Loss of Osseointegration 31 31
Unintended Movement 29 29
Inadequacy of Device Shape and/or Size 28 28
Device Appears to Trigger Rejection 27 27
Noise, Audible 25 25
Material Separation 24 24
Positioning Failure 24 24
Improper or Incorrect Procedure or Method 23 23
Defective Device 23 23
No Apparent Adverse Event 23 23
Device Slipped 22 22
Material Erosion 21 21
Material Integrity Problem 18 18
Off-Label Use 16 16
Patient-Device Incompatibility 16 16
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
Fitting Problem 11 11
Use of Device Problem 11 11
Difficult to Remove 11 11
Material Fragmentation 10 10
Output Problem 10 10
Crack 8 8
Degraded 8 8
Loss of or Failure to Bond 8 8
Mechanical Problem 8 8
Device Operates Differently Than Expected 8 8
Separation Failure 8 8
Unexpected Therapeutic Results 7 7
Corroded 7 7
Material Twisted/Bent 7 7
Physical Resistance/Sticking 7 7
Device Damaged Prior to Use 5 5
Dull, Blunt 5 5
Component Missing 3 3
Structural Problem 3 3
Failure to Osseointegrate 3 3
Device Markings/Labelling 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
Difficult or Delayed Separation 3 3
Scratched Material 3 3
Packaging Problem 3 3
Material Protrusion/Extrusion 3 3
Compatibility Problem 3 3
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
Lack of Effect 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
Tear, Rip or Hole in Device Packaging 2 2
Residue After Decontamination 1 1
Failure to Align 1 1
Failure to Advance 1 1
Unraveled Material 1 1
Defective Component 1 1
Excessive Cooling 1 1
Device Operational Issue 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 1146 1146
Joint Dislocation 1128 1128
Insufficient Information 741 741
Pain 667 668
Failure of Implant 634 634
No Clinical Signs, Symptoms or Conditions 528 528
No Code Available 441 441
Joint Laxity 386 386
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 312 312
No Known Impact Or Consequence To Patient 251 251
Fall 177 177
Bone Fracture(s) 166 166
Inadequate Osseointegration 154 154
Loss of Range of Motion 140 140
Implant Pain 131 131
No Information 82 82
Foreign Body In Patient 64 64
Subluxation 62 62
Osteolysis 60 60
Osteopenia/ Osteoporosis 55 55
Hematoma 48 48
Metal Related Pathology 43 43
Unspecified Tissue Injury 43 43
Erosion 38 38
Bacterial Infection 30 30
Limited Mobility Of The Implanted Joint 30 30
Discomfort 29 29
Nerve Damage 28 28
Swelling/ Edema 28 28
Muscle/Tendon Damage 27 27
Ossification 26 26
Hypersensitivity/Allergic reaction 25 25
Device Embedded In Tissue or Plaque 23 23
Inflammation 21 21
Adhesion(s) 21 21
No Consequences Or Impact To Patient 19 19
Fever 18 18
Pulmonary Embolism 17 17
Limb Fracture 17 17
Anemia 16 16
Foreign Body Reaction 16 16
Joint Disorder 16 16
Impaired Healing 15 15
Muscular Rigidity 15 15
Sepsis 15 15
Scar Tissue 14 14
Rheumatoid Arthritis 14 14
Swelling 13 14
Synovitis 13 14
Injury 13 13
Cyst(s) 11 11
Muscle Weakness 11 11
Numbness 11 11
Localized Skin Lesion 10 10
Abdominal Pain 9 9
Toxicity 9 9
Post Operative Wound Infection 9 9
Skin Discoloration 8 8
Pneumonia 8 8
Wound Dehiscence 8 8
Thrombosis/Thrombus 8 8
Damage to Ligament(s) 7 7
Neuropathy 7 7
Rash 7 7
Urinary Tract Infection 7 7
Non-union Bone Fracture 7 7
Arthralgia 6 6
Reaction 6 6
Paralysis 6 6
Fatigue 6 6
Peripheral Nervous Injury 6 6
Unspecified Musculoskeletal problem 6 6
Patient Problem/Medical Problem 6 6
Fluid Discharge 5 5
Sweating 5 5
Tissue Breakdown 5 5
Unspecified Mental, Emotional or Behavioural Problem 5 5
Arthritis 5 5
Weakness 5 5
Tissue Damage 5 5
Bruise/Contusion 4 4
Stroke/CVA 4 4
Extravasation 4 4
Erythema 3 3
Seroma 3 3
Ambulation Difficulties 3 3
Fracture, Arm 3 3
Hyperextension 3 3
Muscle Hypotonia 3 3
No Patient Involvement 3 3
Skin Infection 2 2
Urinary Frequency 2 2
Cognitive Changes 2 2
Confusion/ Disorientation 2 2
Burning Sensation 2 2
Dizziness 2 2
Atrial Fibrillation 2 2
Abrasion 1 1
Death 1 1
Edema 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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