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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, shoulder, non-constrained, metal/polymer cemented
Regulation Description Shoulder joint metal/polymer non-constrained cemented prosthesis.
Product CodeKWT
Regulation Number 888.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 2
SHOULDER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 216 216
2021 228 228
2022 274 274
2023 379 379
2024 618 618
2025 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 642 642
Device Dislodged or Dislocated 305 305
Loosening of Implant Not Related to Bone-Ingrowth 196 196
Detachment of Device or Device Component 161 161
Fracture 157 157
Naturally Worn 99 99
Break 71 71
Insufficient Information 63 63
Unstable 52 52
Appropriate Term/Code Not Available 27 27
Patient Device Interaction Problem 19 19
Migration 19 19
Loss of or Failure to Bond 10 10
Inadequacy of Device Shape and/or Size 9 9
Material Erosion 8 8
Unintended Movement 6 6
Mechanical Problem 6 6
Patient-Device Incompatibility 4 4
Difficult to Insert 4 4
Loss of Osseointegration 4 4
Defective Device 3 3
Misassembly by Users 3 3
Malposition of Device 3 3
Activation, Positioning or Separation Problem 3 3
Loose or Intermittent Connection 3 3
Noise, Audible 3 3
Contamination /Decontamination Problem 3 3
Material Integrity Problem 2 2
Separation Problem 2 2
Inaccurate Information 2 2
Lack of Effect 2 2
Unintended Collision 2 2
Positioning Problem 2 2
Migration or Expulsion of Device 2 2
Biocompatibility 2 2
Fitting Problem 2 2
Off-Label Use 2 2
Improper or Incorrect Procedure or Method 2 2
Separation Failure 2 2
Material Puncture/Hole 1 1
Device-Device Incompatibility 1 1
Disconnection 1 1
Difficult to Remove 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Connection Problem 1 1
Measurement System Incompatibility 1 1
Failure to Align 1 1
Device Fell 1 1
Difficult to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 544 544
Joint Dislocation 262 262
Pain 224 224
Insufficient Information 181 181
Bacterial Infection 162 162
Bone Fracture(s) 120 120
Unspecified Infection 96 96
No Clinical Signs, Symptoms or Conditions 75 75
Loss of Range of Motion 51 51
Joint Laxity 47 47
Muscle/Tendon Damage 40 40
Metal Related Pathology 26 26
Osteolysis 26 26
Implant Pain 21 21
Subluxation 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Inadequate Osseointegration 16 16
No Information 14 14
No Code Available 14 14
Erosion 14 14
No Consequences Or Impact To Patient 13 13
Fall 13 13
Unspecified Tissue Injury 12 12
Device Embedded In Tissue or Plaque 8 8
Osteopenia/ Osteoporosis 7 7
Swelling/ Edema 7 7
Foreign Body In Patient 6 6
Inflammation 5 5
Wound Dehiscence 5 5
Necrosis 5 5
Limb Fracture 4 4
No Known Impact Or Consequence To Patient 4 4
Hematoma 4 4
Nerve Damage 4 4
Numbness 4 4
Erythema 4 4
Unspecified Musculoskeletal problem 3 3
Discomfort 3 3
Injury 3 3
Ossification 3 3
Granuloma 2 2
Purulent Discharge 2 2
Connective Tissue Disease 2 2
Stroke/CVA 2 2
Arthritis 2 2
Cognitive Changes 2 2
Post Traumatic Wound Infection 2 2
Post Operative Wound Infection 2 2
Impaired Healing 2 2
Non-union Bone Fracture 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jan-18-2024
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