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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 1
FX SHOULDER USA, INC
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
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 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 1926 1926
Appropriate Term/Code Not Available 1322 1322
Device Dislodged or Dislocated 1282 1282
Fracture 382 382
Unstable 303 303
Break 297 297
Loosening of Implant Not Related to Bone-Ingrowth 194 194
Detachment of Device or Device Component 169 169
Loose or Intermittent Connection 152 152
Osseointegration Problem 134 134
Difficult to Insert 96 96
Patient Device Interaction Problem 88 88
Insufficient Information 77 77
Naturally Worn 64 64
Migration 47 47
Device-Device Incompatibility 44 44
Microbial Contamination of Device 42 42
Malposition of Device 41 41
Loss of Osseointegration 31 31
Material Deformation 29 29
Positioning Problem 26 26
Unintended Movement 25 25
Inadequacy of Device Shape and/or Size 25 25
Device Appears to Trigger Rejection 24 24
Noise, Audible 23 23
Positioning Failure 22 22
Material Separation 22 22
Improper or Incorrect Procedure or Method 22 22
Material Erosion 21 21
No Apparent Adverse Event 19 19
Off-Label Use 16 16
Device Slipped 15 15
Defective Device 15 15
Patient-Device Incompatibility 13 13
Biocompatibility 13 13
Therapeutic or Diagnostic Output Failure 13 13
Mechanical Jam 13 13
Difficult to Advance 12 12
Material Integrity Problem 12 12
Migration or Expulsion of Device 12 12
Output Problem 10 10
Difficult to Remove 9 9
Use of Device Problem 9 9
Crack 8 8
Degraded 8 8
Loss of or Failure to Bond 8 8
Mechanical Problem 8 8
Separation Failure 8 8
Material Fragmentation 7 7
Corroded 7 7
Unexpected Therapeutic Results 7 7
Material Twisted/Bent 6 6
Physical Resistance/Sticking 6 6
Fitting Problem 5 5
Device Damaged Prior to Use 4 4
Dull, Blunt 4 4
Difficult to Open or Close 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Material Protrusion/Extrusion 3 3
Structural Problem 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
Tear, Rip or Hole in Device Packaging 2 2
Component Missing 2 2
Environmental Particulates 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
Failure to Osseointegrate 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
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
Excessive Cooling 1 1
Residue After Decontamination 1 1
Defective Component 1 1
Failure to Align 1 1
Failure to Advance 1 1
Contamination /Decontamination Problem 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 1060 1060
Joint Dislocation 1009 1009
Insufficient Information 710 710
Pain 586 587
Failure of Implant 584 584
No Clinical Signs, Symptoms or Conditions 495 495
Joint Laxity 368 368
No Code Available 317 317
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 311 311
No Known Impact Or Consequence To Patient 225 225
Fall 172 172
Inadequate Osseointegration 151 151
Bone Fracture(s) 145 145
Implant Pain 121 121
Loss of Range of Motion 117 117
Subluxation 59 59
Foreign Body In Patient 57 57
No Information 56 56
Osteolysis 54 54
Osteopenia/ Osteoporosis 50 50
Hematoma 46 46
Metal Related Pathology 43 43
Unspecified Tissue Injury 40 40
Erosion 37 37
Nerve Damage 28 28
Bacterial Infection 27 27
Ossification 26 26
Discomfort 25 25
Muscle/Tendon Damage 22 22
Limited Mobility Of The Implanted Joint 21 21
Swelling/ Edema 19 19
Pulmonary Embolism 17 17
Anemia 16 16
Foreign Body Reaction 16 16
Hypersensitivity/Allergic reaction 16 16
No Consequences Or Impact To Patient 16 16
Device Embedded In Tissue or Plaque 16 16
Limb Fracture 15 15
Muscular Rigidity 15 15
Scar Tissue 14 14
Sepsis 14 14
Impaired Healing 14 14
Rheumatoid Arthritis 14 14
Joint Disorder 13 13
Synovitis 13 14
Swelling 11 12
Numbness 11 11
Adhesion(s) 11 11
Inflammation 11 11
Muscle Weakness 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
Fever 7 7
Urinary Tract Infection 7 7
Non-union Bone Fracture 7 7
Arthralgia 6 6
Fatigue 6 6
Paralysis 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
Stroke/CVA 4 4
Extravasation 4 4
Erythema 3 3
Rash 3 3
Seroma 3 3
Injury 3 3
Fracture, Arm 3 3
No Patient Involvement 3 3
Muscle Hypotonia 3 3
Skin Infection 2 2
Ambulation Difficulties 2 2
Confusion/ Disorientation 2 2
Reaction 2 2
Tissue Damage 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
Abrasion 1 1
Impotence 1 1
Rupture 1 1
Discharge 1 1
Burning Sensation 1 1
Bone Shedding Debris 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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