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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, uncemented
Regulation Description Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
Product CodeMBF
Regulation Number 888.3670
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 3
IGNITE ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 24 24
2021 36 36
2022 116 116
2023 143 143
2024 165 165
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 214 214
Break 96 96
Loosening of Implant Not Related to Bone-Ingrowth 46 46
Device Dislodged or Dislocated 32 32
Device-Device Incompatibility 29 29
Insufficient Information 20 20
Naturally Worn 20 20
Fracture 19 19
Patient Device Interaction Problem 12 12
Detachment of Device or Device Component 11 11
Material Deformation 10 10
Unstable 9 9
Loss of or Failure to Bond 6 6
Migration 6 6
Material Erosion 5 5
Osseointegration Problem 4 4
Defective Device 4 4
Scratched Material 4 4
Difficult to Insert 4 4
Unintended Movement 3 3
Noise, Audible 3 3
Appropriate Term/Code Not Available 3 3
Material Separation 2 2
Loose or Intermittent Connection 2 2
Loss of Osseointegration 2 2
Failure to Cut 2 2
Improper or Incorrect Procedure or Method 2 2
Device Markings/Labelling Problem 1 1
Material Fragmentation 1 1
Mechanical Problem 1 1
Material Integrity Problem 1 1
Malposition of Device 1 1
Positioning Failure 1 1
Packaging Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Component Incompatible 1 1
No Apparent Adverse Event 1 1
Failure to Advance 1 1
Delivered as Unsterile Product 1 1
Separation Failure 1 1
Difficult to Remove 1 1
Off-Label Use 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 121 121
Pain 82 82
Insufficient Information 81 81
Failure of Implant 64 64
Unspecified Tissue Injury 48 48
Joint Dislocation 27 27
Bone Fracture(s) 26 26
Muscle/Tendon Damage 25 25
Loss of Range of Motion 24 24
Unspecified Infection 23 23
Joint Laxity 20 20
Subluxation 19 19
Hematoma 13 13
Fluid Discharge 12 12
Erosion 12 12
Metal Related Pathology 12 12
Osteolysis 8 8
Thrombosis/Thrombus 7 7
Osteopenia/ Osteoporosis 7 7
Synovitis 6 6
Inflammation 6 6
Discomfort 5 5
Impaired Healing 4 4
Foreign Body In Patient 4 4
Limited Mobility Of The Implanted Joint 4 4
Inadequate Osseointegration 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Implant Pain 4 4
Arthritis 4 4
Adhesion(s) 4 4
Pulmonary Embolism 4 4
Scar Tissue 4 4
Muscular Rigidity 4 4
Hypersensitivity/Allergic reaction 3 3
Wound Dehiscence 3 3
Fall 2 2
Swelling/ Edema 2 2
Rheumatoid Arthritis 2 2
No Known Impact Or Consequence To Patient 2 2
Low Blood Pressure/ Hypotension 1 1
Localized Skin Lesion 1 1
Fever 1 1
Purulent Discharge 1 1
Cyst(s) 1 1
Abdominal Pain 1 1
Tissue Breakdown 1 1
Ossification 1 1
No Code Available 1 1
Arthralgia 1 1
Non-union Bone Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Feb-24-2022
2 Biomet, Inc. II Mar-03-2020
3 Limacorporate S.p.A II Jan-12-2024
4 Limacorporate S.p.A II Jun-27-2023
5 Limacorporate S.p.A II Apr-01-2023
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