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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
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
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 5
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 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 6
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 2
FH INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 3
FIX SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
FX SHOULDER USA, INC
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION (TORNIER, S.A.S.)
  SUBSTANTIALLY EQUIVALENT 1
SYMMETRY MEDICAL MANUFACTURING INC. DBA TECOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 986 986
2021 1410 1410
2022 1340 1340
2023 1416 1416
2024 2147 2147
2025 1013 1017

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3158 3158
Device Dislodged or Dislocated 1527 1527
Appropriate Term/Code Not Available 1196 1196
Fracture 563 563
Unstable 402 402
Loosening of Implant Not Related to Bone-Ingrowth 336 336
Break 326 326
Detachment of Device or Device Component 265 265
Patient Device Interaction Problem 190 190
Osseointegration Problem 158 158
Difficult to Insert 139 139
Loose or Intermittent Connection 132 132
Insufficient Information 96 100
Naturally Worn 94 94
Migration 83 83
Positioning Failure 63 63
Device-Device Incompatibility 60 60
Device Appears to Trigger Rejection 51 51
Unintended Movement 44 44
Malposition of Device 44 44
Material Deformation 42 42
Defective Device 39 39
Microbial Contamination of Device 37 37
Loss of Osseointegration 36 36
No Apparent Adverse Event 32 32
Material Erosion 28 28
Improper or Incorrect Procedure or Method 26 26
Noise, Audible 25 25
Inadequacy of Device Shape and/or Size 23 23
Material Separation 21 21
Positioning Problem 21 21
Fitting Problem 16 16
Off-Label Use 16 16
Mechanical Jam 16 16
Use of Device Problem 13 13
Biocompatibility 13 13
Therapeutic or Diagnostic Output Failure 13 13
Mechanical Problem 11 11
Degraded 11 11
Patient-Device Incompatibility 10 10
Output Problem 10 10
Crack 10 10
Material Integrity Problem 9 9
Difficult to Remove 9 9
Difficult to Advance 9 9
Migration or Expulsion of Device 8 8
Physical Resistance/Sticking 8 8
Dull, Blunt 7 7
Unexpected Therapeutic Results 7 7
Failure to Osseointegrate 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Dislocation 1580 1580
Unspecified Infection 1429 1429
Insufficient Information 951 951
No Clinical Signs, Symptoms or Conditions 810 810
Pain 767 768
Failure of Implant 752 752
Joint Laxity 682 682
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 322 322
No Code Available 240 240
Implant Pain 234 234
Bone Fracture(s) 229 229
Inadequate Osseointegration 217 217
Loss of Range of Motion 173 173
Fall 168 168
No Known Impact Or Consequence To Patient 111 111
Subluxation 90 90
Foreign Body In Patient 85 85
Osteolysis 80 80
Osteopenia/ Osteoporosis 72 72
Metal Related Pathology 62 62
Hematoma 55 55
Unspecified Tissue Injury 52 52
Erosion 47 47
Bacterial Infection 43 43
Swelling/ Edema 40 40
Nerve Damage 32 32
Discomfort 32 32
Muscle/Tendon Damage 32 32
Inflammation 30 30
No Information 29 29
Ossification 27 27
Hypersensitivity/Allergic reaction 26 26
Fever 26 26
Foreign Body Reaction 24 24
Limb Fracture 23 23
Adhesion(s) 21 21
Sepsis 17 17
Numbness 17 17
Non-union Bone Fracture 17 17
Limited Mobility Of The Implanted Joint 15 15
Muscular Rigidity 15 15
Thrombosis/Thrombus 15 15
Scar Tissue 14 14
Rheumatoid Arthritis 14 14
Unspecified Musculoskeletal problem 13 13
Synovitis 13 14
Malunion of Bone 13 13
Impaired Healing 13 13
Cyst(s) 12 12
Muscle Weakness 11 11

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 Jun-23-2025
9 Encore Medical, LP II Jan-02-2024
10 Encore Medical, LP II Dec-12-2023
11 Encore Medical, LP II Nov-08-2023
12 Encore Medical, LP II Oct-12-2023
13 Encore Medical, LP II Sep-19-2023
14 Encore Medical, LP II Sep-25-2020
15 Exactech, Inc. II Mar-29-2024
16 Exactech, Inc. II Jun-29-2021
17 Exactech, Inc. II Oct-29-2020
18 Exactech, Inc. II Sep-25-2020
19 Exactech, Inc. II Jan-28-2020
20 FX SHOULDER II Jan-29-2024
21 Limacorporate S.p.A II Jun-25-2025
22 Tornier S.A.S. II May-08-2025
23 Tornier S.A.S. II May-22-2024
24 Tornier, Inc II Jan-19-2024
25 Tornier, Inc II Oct-13-2023
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