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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 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
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH INC.
  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 1417 1417
2024 1123 1123

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2247 2247
Device Dislodged or Dislocated 1392 1392
Appropriate Term/Code Not Available 1324 1324
Fracture 423 423
Unstable 333 333
Break 308 308
Loosening of Implant Not Related to Bone-Ingrowth 222 222
Detachment of Device or Device Component 185 185
Loose or Intermittent Connection 152 152
Osseointegration Problem 137 137
Difficult to Insert 105 105
Patient Device Interaction Problem 92 92
Insufficient Information 83 83
Naturally Worn 74 74
Migration 60 60
Device-Device Incompatibility 44 44
Malposition of Device 42 42
Microbial Contamination of Device 42 42
Loss of Osseointegration 32 32
Device Appears to Trigger Rejection 32 32
Material Deformation 32 32
Positioning Failure 30 30
Unintended Movement 29 29
No Apparent Adverse Event 28 28
Material Erosion 27 27
Positioning Problem 26 26
Noise, Audible 25 25
Inadequacy of Device Shape and/or Size 25 25
Defective Device 24 24
Improper or Incorrect Procedure or Method 22 22
Material Separation 22 22
Off-Label Use 16 16
Device Slipped 15 15
Material Integrity Problem 14 14
Mechanical Jam 13 13
Therapeutic or Diagnostic Output Failure 13 13
Patient-Device Incompatibility 13 13
Biocompatibility 13 13
Difficult to Advance 12 12
Fitting Problem 12 12
Migration or Expulsion of Device 12 12
Use of Device Problem 10 10
Output Problem 10 10
Mechanical Problem 9 9
Difficult to Remove 9 9
Material Fragmentation 9 9
Loss of or Failure to Bond 9 9
Crack 8 8
Degraded 8 8
Separation Failure 8 8
Physical Resistance/Sticking 8 8
Material Twisted/Bent 7 7
Corroded 7 7
Unexpected Therapeutic Results 7 7
Dull, Blunt 6 6
Device Damaged Prior to Use 5 5
Device Difficult to Setup or Prepare 5 5
Packaging Problem 4 4
Material Protrusion/Extrusion 3 3
Difficult or Delayed Separation 3 3
Failure to Osseointegrate 3 3
Structural Problem 3 3
Difficult to Open or Close 3 3
Device Markings/Labelling Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Expulsion 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
Tear, Rip or Hole in Device Packaging 2 2
Component Missing 2 2
Defective Component 2 2
Unsealed Device Packaging 2 2
Delivered as Unsterile Product 2 2
Entrapment of Device 2 2
Material Frayed 2 2
Labelling, Instructions for Use or Training Problem 2 2
Disconnection 2 2
Lack of Effect 2 2
Environmental Particulates 2 2
Mechanics Altered 2 2
Scratched Material 2 2
Excessive Cooling 1 1
Premature Separation 1 1
Inaccurate Information 1 1
Separation Problem 1 1
Material Disintegration 1 1
Signal Artifact/Noise 1 1
Computer Software Problem 1 1
Flaked 1 1
Unintended System Motion 1 1
Nonstandard Device 1 1
Unraveled Material 1 1
Problem with Sterilization 1 1
Material Rupture 1 1
Residue After Decontamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1174 1174
Joint Dislocation 1167 1167
Insufficient Information 779 779
Pain 646 647
Failure of Implant 625 625
No Clinical Signs, Symptoms or Conditions 570 570
Joint Laxity 455 455
No Code Available 317 317
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 314 314
No Known Impact Or Consequence To Patient 225 225
Fall 172 172
Bone Fracture(s) 164 164
Inadequate Osseointegration 159 159
Implant Pain 147 147
Loss of Range of Motion 139 139
Osteolysis 67 67
Foreign Body In Patient 64 64
Subluxation 62 62
Osteopenia/ Osteoporosis 58 58
No Information 56 56
Hematoma 48 48
Unspecified Tissue Injury 47 47
Metal Related Pathology 44 44
Erosion 44 44
Bacterial Infection 33 33
Swelling/ Edema 33 33
Nerve Damage 29 29
Ossification 27 27
Muscle/Tendon Damage 27 27
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 19 19
Pulmonary Embolism 17 17
Foreign Body Reaction 17 17
Fever 16 16
Anemia 16 16
No Consequences Or Impact To Patient 16 16
Device Embedded In Tissue or Plaque 16 16
Muscular Rigidity 15 15
Scar Tissue 14 14
Sepsis 14 14
Impaired Healing 14 14
Rheumatoid Arthritis 14 14
Synovitis 13 14
Joint Disorder 13 13
Numbness 11 11
Swelling 11 12
Cyst(s) 11 11
Muscle Weakness 11 11
Localized Skin Lesion 10 10
Abdominal Pain 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
Paralysis 7 7
Urinary Tract Infection 7 7
Non-union Bone Fracture 7 7
Arthralgia 6 6
Fatigue 6 6
Peripheral Nervous Injury 6 6
Patient Problem/Medical Problem 6 6
Unspecified Musculoskeletal problem 6 6
Unspecified Mental, Emotional or Behavioural Problem 5 5
Sweating 5 5
Tissue Breakdown 5 5
Fluid Discharge 5 5
Arthritis 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
No Patient Involvement 3 3
Muscle Hypotonia 3 3
Hyperextension 3 3
Skin Infection 2 2
Urinary Frequency 2 2
Ambulation Difficulties 2 2
Cognitive Changes 2 2
Confusion/ Disorientation 2 2
Reaction 2 2
Burning Sensation 2 2
Dizziness 2 2
Tissue Damage 2 2
Atrial Fibrillation 2 2
Abrasion 1 1
Calcium Deposits/Calcification 1 1
Hemorrhage/Bleeding 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 S.A.S. II May-22-2024
22 Tornier, Inc II Jan-19-2024
23 Tornier, Inc II Oct-13-2023
24 Tornier, Inc II Nov-14-2019
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