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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 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 11
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH INC.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 9
FH INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
FIX SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 4
FX SHOULDER USA, INC
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
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 986 986
2021 1410 1410
2022 1341 1341
2023 1417 1417
2024 1445 1445

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2491 2491
Device Dislodged or Dislocated 1546 1546
Appropriate Term/Code Not Available 1345 1345
Fracture 458 458
Unstable 381 381
Break 333 333
Loosening of Implant Not Related to Bone-Ingrowth 232 232
Detachment of Device or Device Component 205 205
Loose or Intermittent Connection 175 175
Osseointegration Problem 138 138
Patient Device Interaction Problem 122 122
Difficult to Insert 109 109
Insufficient Information 102 102
Naturally Worn 85 85
Migration 68 68
Device-Device Incompatibility 45 45
Malposition of Device 44 44
Microbial Contamination of Device 42 42
Positioning Failure 40 40
Material Deformation 35 35
Device Appears to Trigger Rejection 34 34
Positioning Problem 34 34
Loss of Osseointegration 32 32
Unintended Movement 32 32
No Apparent Adverse Event 28 28
Material Erosion 28 28
Inadequacy of Device Shape and/or Size 28 28
Noise, Audible 25 25
Defective Device 24 24
Material Separation 24 24
Improper or Incorrect Procedure or Method 23 23
Device Slipped 22 22
Material Integrity Problem 19 19
Patient-Device Incompatibility 16 16
Off-Label Use 16 16
Migration or Expulsion of Device 15 15
Mechanical Jam 14 14
Difficult to Advance 13 13
Therapeutic or Diagnostic Output Failure 13 13
Biocompatibility 13 13
Fitting Problem 12 12
Use of Device Problem 11 11
Difficult to Remove 11 11
Physical Resistance/Sticking 10 10
Output Problem 10 10
Material Fragmentation 10 10
Loss of or Failure to Bond 9 9
Mechanical Problem 9 9
Degraded 8 8
Device Operates Differently Than Expected 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Dislocation 1306 1306
Unspecified Infection 1302 1302
Insufficient Information 807 807
Pain 727 728
Failure of Implant 674 674
No Clinical Signs, Symptoms or Conditions 598 598
Joint Laxity 480 480
No Code Available 441 441
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 314 314
No Known Impact Or Consequence To Patient 251 251
Bone Fracture(s) 182 182
Fall 177 177
Inadequate Osseointegration 162 162
Implant Pain 162 162
Loss of Range of Motion 156 156
No Information 83 83
Foreign Body In Patient 71 71
Osteolysis 68 68
Subluxation 62 62
Osteopenia/ Osteoporosis 58 58
Hematoma 51 51
Unspecified Tissue Injury 47 47
Metal Related Pathology 47 47
Erosion 44 44
Bacterial Infection 34 34
Swelling/ Edema 34 34
Muscle/Tendon Damage 30 30
Discomfort 30 30
Limited Mobility Of The Implanted Joint 30 30
Nerve Damage 29 29
Inflammation 28 28
Ossification 27 27
Hypersensitivity/Allergic reaction 25 25
Device Embedded In Tissue or Plaque 23 23
Adhesion(s) 21 21
Limb Fracture 21 21
Fever 21 21
No Consequences Or Impact To Patient 19 19
Pulmonary Embolism 17 17
Foreign Body Reaction 17 17
Sepsis 17 17
Muscular Rigidity 17 17
Anemia 16 16
Joint Disorder 16 16
Impaired Healing 15 15
Scar Tissue 14 14
Rheumatoid Arthritis 14 14
Numbness 14 14
Synovitis 13 14
Swelling 13 14

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 S.A.S. II May-22-2024
25 Tornier, Inc II Jan-19-2024
26 Tornier, Inc II Oct-13-2023
27 Tornier, Inc II Nov-14-2019
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