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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 6
ARTHROSURFACE INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 3
CATALYST ORTHOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 5
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 6
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY(IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 3
FH INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
FIX SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
FX SHOULDER USA, INC
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYMMETRY MEDICAL MANUFACTURING INC. DBA TECOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 4
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 2062 2062
Device Dislodged or Dislocated 1337 1337
Appropriate Term/Code Not Available 1323 1323
Fracture 395 395
Unstable 312 312
Break 301 301
Loosening of Implant Not Related to Bone-Ingrowth 214 214
Detachment of Device or Device Component 174 174
Loose or Intermittent Connection 152 152
Osseointegration Problem 135 135
Difficult to Insert 102 102
Patient Device Interaction Problem 89 89
Insufficient Information 79 79
Naturally Worn 70 70
Migration 51 51
Device-Device Incompatibility 44 44
Microbial Contamination of Device 42 42
Malposition of Device 42 42
Loss of Osseointegration 31 31
Material Deformation 31 31
Device Appears to Trigger Rejection 27 27
Unintended Movement 26 26
Positioning Problem 26 26
Noise, Audible 25 25
Inadequacy of Device Shape and/or Size 25 25
Positioning Failure 24 24
Defective Device 23 23
No Apparent Adverse Event 23 23
Material Separation 22 22
Improper or Incorrect Procedure or Method 22 22
Material Erosion 21 21
Off-Label Use 16 16
Device Slipped 15 15
Patient-Device Incompatibility 13 13
Biocompatibility 13 13
Material Integrity Problem 13 13
Therapeutic or Diagnostic Output Failure 13 13
Mechanical Jam 13 13
Difficult to Advance 12 12
Migration or Expulsion of Device 12 12
Fitting Problem 11 11
Use of Device Problem 10 10
Output Problem 10 10
Difficult to Remove 9 9
Material Fragmentation 9 9
Mechanical Problem 8 8
Crack 8 8
Degraded 8 8
Loss of or Failure to Bond 8 8
Separation Failure 8 8
Material Twisted/Bent 7 7
Corroded 7 7
Unexpected Therapeutic Results 7 7
Physical Resistance/Sticking 6 6
Dull, Blunt 5 5
Device Damaged Prior to Use 5 5
Structural Problem 3 3
Device Markings/Labelling Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Difficult to Open or Close 3 3
Material Protrusion/Extrusion 3 3
Failure to Osseointegrate 3 3
Difficult or Delayed Separation 3 3
Packaging Problem 3 3
Mechanics Altered 2 2
Scratched Material 2 2
Lack of Effect 2 2
Unsealed Device Packaging 2 2
Device Difficult to Setup or Prepare 2 2
Entrapment of Device 2 2
Material Frayed 2 2
Labelling, Instructions for Use or Training Problem 2 2
Disconnection 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
Environmental Particulates 2 2
Tear, Rip or Hole in Device Packaging 2 2
Component Missing 2 2
Residue After Decontamination 1 1
Defective Component 1 1
Failure to Align 1 1
Failure to Advance 1 1
Contamination /Decontamination Problem 1 1
Excessive Cooling 1 1
Material Disintegration 1 1
Signal Artifact/Noise 1 1
Computer Software Problem 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Unraveled Material 1 1
Material Rupture 1 1
Problem with Sterilization 1 1
Premature Separation 1 1
Inaccurate Information 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1102 1102
Joint Dislocation 1080 1080
Insufficient Information 741 741
Pain 621 622
Failure of Implant 603 603
No Clinical Signs, Symptoms or Conditions 527 527
Joint Laxity 386 386
No Code Available 317 317
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 312 312
No Known Impact Or Consequence To Patient 225 225
Fall 172 172
Bone Fracture(s) 161 161
Inadequate Osseointegration 154 154
Loss of Range of Motion 132 132
Implant Pain 131 131
Subluxation 62 62
Osteolysis 60 60
Foreign Body In Patient 58 58
No Information 56 56
Osteopenia/ Osteoporosis 55 55
Hematoma 46 46
Unspecified Tissue Injury 43 43
Metal Related Pathology 43 43
Erosion 38 38
Bacterial Infection 30 30
Nerve Damage 28 28
Swelling/ Edema 28 28
Muscle/Tendon Damage 27 27
Ossification 26 26
Discomfort 26 26
Hypersensitivity/Allergic reaction 25 25
Inflammation 21 21
Adhesion(s) 21 21
Limited Mobility Of The Implanted Joint 21 21
Limb Fracture 17 17
Pulmonary Embolism 17 17
Anemia 16 16
Fever 16 16
Foreign Body Reaction 16 16
No Consequences Or Impact To Patient 16 16
Device Embedded In Tissue or Plaque 16 16
Muscular Rigidity 15 15
Rheumatoid Arthritis 14 14
Scar Tissue 14 14
Sepsis 14 14
Impaired Healing 14 14
Synovitis 13 14
Joint Disorder 13 13
Swelling 11 12
Numbness 11 11
Cyst(s) 11 11
Muscle Weakness 11 11
Localized Skin Lesion 10 10
Abdominal Pain 9 9
Post Operative Wound Infection 9 9
Pneumonia 8 8
Skin Discoloration 8 8
Wound Dehiscence 8 8
Thrombosis/Thrombus 8 8
Damage to Ligament(s) 7 7
Neuropathy 7 7
Urinary Tract Infection 7 7
Non-union Bone Fracture 7 7
Arthralgia 6 6
Paralysis 6 6
Fatigue 6 6
Peripheral Nervous Injury 6 6
Patient Problem/Medical Problem 6 6
Unspecified Musculoskeletal problem 6 6
Tissue Breakdown 5 5
Fluid Discharge 5 5
Unspecified Mental, Emotional or Behavioural Problem 5 5
Arthritis 5 5
Sweating 5 5
Toxicity 5 5
Weakness 5 5
Rash 4 4
Bruise/Contusion 4 4
Stroke/CVA 4 4
Extravasation 4 4
Erythema 3 3
Seroma 3 3
Injury 3 3
Fracture, Arm 3 3
Hyperextension 3 3
No Patient Involvement 3 3
Muscle Hypotonia 3 3
Skin Infection 2 2
Reaction 2 2
Ambulation Difficulties 2 2
Cognitive Changes 2 2
Confusion/ Disorientation 2 2
Tissue Damage 2 2
Burning Sensation 2 2
Dizziness 2 2
Urinary Frequency 2 2
Atrial Fibrillation 2 2
Abrasion 1 1
Calcium Deposits/Calcification 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 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 Exactech, Inc. II Mar-29-2024
15 Exactech, Inc. II Jun-29-2021
16 Exactech, Inc. II Oct-29-2020
17 Exactech, Inc. II Sep-25-2020
18 Exactech, Inc. II Jan-28-2020
19 Exactech, Inc. II Feb-26-2019
20 FX SHOULDER II Jan-29-2024
21 Tornier, Inc II Jan-19-2024
22 Tornier, Inc II Oct-13-2023
23 Tornier, Inc II Nov-14-2019
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