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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, shoulder, semi-constrained, metal/polymer cemented
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Product CodeKWS
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY LNC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORPORATION (TORNIER, INC.)
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 2
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1567 1567
2021 1358 1358
2022 1272 1372
2023 1734 1743
2024 2104 2104
2025 185 185

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3577 3623
Device Dislodged or Dislocated 1065 1110
Fracture 881 896
Appropriate Term/Code Not Available 656 656
Loosening of Implant Not Related to Bone-Ingrowth 463 465
Unstable 409 445
Break 350 361
Insufficient Information 219 219
Detachment of Device or Device Component 211 211
Migration 180 193
Naturally Worn 175 175
Osseointegration Problem 171 181
Loss of Osseointegration 151 151
Loose or Intermittent Connection 115 115
Patient Device Interaction Problem 81 81
Difficult to Insert 52 52
Malposition of Device 49 49
Loss of or Failure to Bond 41 41
Material Fragmentation 32 32
Noise, Audible 32 32
Inadequacy of Device Shape and/or Size 29 29
Therapeutic or Diagnostic Output Failure 27 27
Positioning Failure 26 26
Material Integrity Problem 26 26
Material Twisted/Bent 25 25
Unintended Movement 24 24
Mechanical Jam 23 23
Failure to Osseointegrate 21 21
Migration or Expulsion of Device 19 19
Material Separation 19 19
Use of Device Problem 18 18
Crack 18 18
Material Erosion 17 17
No Apparent Adverse Event 17 17
Inaccurate Information 16 16
Degraded 15 15
Device Contaminated During Manufacture or Shipping 14 14
Positioning Problem 14 14
Mechanical Problem 14 14
Difficult to Remove 12 12
Device-Device Incompatibility 12 12
Off-Label Use 12 12
Device Difficult to Setup or Prepare 11 11
Fitting Problem 11 11
Biocompatibility 10 10
Physical Resistance/Sticking 10 10
Packaging Problem 9 9
Device Damaged by Another Device 9 9
Material Deformation 9 9
Dull, Blunt 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1427 1451
Joint Dislocation 1017 1054
Failure of Implant 981 988
No Clinical Signs, Symptoms or Conditions 926 926
Insufficient Information 848 895
Pain 830 830
Joint Laxity 584 606
Implant Pain 503 509
No Code Available 387 387
Bone Fracture(s) 330 340
Loss of Range of Motion 303 308
Inadequate Osseointegration 273 283
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 191 191
Fall 182 182
Osteolysis 165 165
Limb Fracture 162 162
Bacterial Infection 119 119
Muscle/Tendon Damage 115 121
No Information 102 102
No Known Impact Or Consequence To Patient 99 99
Discomfort 93 93
Erosion 80 80
Foreign Body In Patient 74 74
Injury 67 67
Ossification 62 62
Subluxation 61 61
Metal Related Pathology 60 60
Limited Mobility Of The Implanted Joint 59 59
Hematoma 58 58
Osteopenia/ Osteoporosis 51 51
No Consequences Or Impact To Patient 46 46
Unspecified Tissue Injury 42 42
Inflammation 42 42
Swelling/ Edema 40 40
Muscle Weakness 35 35
Tissue Damage 35 35
Numbness 28 28
Hypersensitivity/Allergic reaction 27 27
Non-union Bone Fracture 27 27
Fluid Discharge 26 26
Foreign Body Reaction 25 25
Erythema 24 24
Post Operative Wound Infection 23 23
Nerve Damage 23 23
Scar Tissue 21 21
Muscular Rigidity 20 20
Ambulation Difficulties 20 20
Adhesion(s) 20 20
Fever 20 20
Reaction 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II Apr-03-2020
3 Encore Medical, LP II Nov-08-2023
4 Encore Medical, LP II Sep-19-2023
5 Encore Medical, LP II Aug-23-2021
6 Encore Medical, LP II Oct-16-2020
7 Exactech, Inc. II Mar-29-2024
8 Exactech, Inc. II Jan-18-2024
9 Exactech, Inc. II Nov-17-2020
10 Materialise N.V. II Aug-26-2020
11 Medacta Usa Inc II Jan-03-2020
12 Tornier, Inc II Jun-28-2023
13 Tornier, Inc II Jul-12-2021
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