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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Product CodeMBF
Regulation Number 888.3670
Device Class 2


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

MDR Year MDR Reports MDR Events
2019 47 47
2020 24 24
2021 36 36
2022 116 116
2023 143 143
2024 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 189 189
Break 80 80
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Insufficient Information 32 32
Device Dislodged or Dislocated 29 29
Device-Device Incompatibility 21 21
Detachment of Device or Device Component 14 14
Unstable 13 13
Fracture 13 13
Naturally Worn 11 11
Patient Device Interaction Problem 11 11
Material Deformation 7 7
Noise, Audible 7 7
Appropriate Term/Code Not Available 7 7
Migration 5 5
Defective Device 5 5
Material Erosion 5 5
Unintended Movement 5 5
Difficult to Insert 4 4
Scratched Material 3 3
Loss of Osseointegration 3 3
Loss of or Failure to Bond 3 3
Osseointegration Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Material Separation 2 2
Loose or Intermittent Connection 2 2
Packaging Problem 2 2
Mechanical Problem 1 1
Device Slipped 1 1
Device Markings/Labelling Problem 1 1
Positioning Problem 1 1
Malposition of Device 1 1
Material Fragmentation 1 1
Component Incompatible 1 1
Separation Failure 1 1
Off-Label Use 1 1
Failure to Advance 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Integrity Problem 1 1
Migration or Expulsion of Device 1 1
Difficult to Remove 1 1
Patient-Device Incompatibility 1 1
No Apparent Adverse Event 1 1
Shipping Damage or Problem 1 1
Failure to Cut 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 107 107
Pain 87 87
Insufficient Information 63 63
Failure of Implant 51 51
Unspecified Tissue Injury 26 26
Muscle/Tendon Damage 25 25
Loss of Range of Motion 24 24
Unspecified Infection 23 23
Joint Dislocation 21 21
Bone Fracture(s) 21 21
Subluxation 18 18
Joint Laxity 18 18
Hematoma 14 14
Limited Mobility Of The Implanted Joint 13 13
Erosion 11 11
Fluid Discharge 8 8
Metal Related Pathology 7 7
Osteopenia/ Osteoporosis 7 7
No Information 6 6
No Code Available 6 6
Osteolysis 6 6
Synovitis 6 6
Inflammation 6 6
Muscular Rigidity 5 5
Discomfort 5 5
Wound Dehiscence 5 5
Numbness 5 5
Foreign Body In Patient 4 4
Implant Pain 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Arthritis 4 4
Fall 4 4
Scar Tissue 4 4
Damage to Ligament(s) 3 3
Tissue Damage 3 3
Hypersensitivity/Allergic reaction 3 3
Adhesion(s) 3 3
Thrombosis/Thrombus 3 3
Swelling/ Edema 2 2
No Known Impact Or Consequence To Patient 2 2
Post Operative Wound Infection 2 2
No Patient Involvement 2 2
Inadequate Osseointegration 2 2
Rheumatoid Arthritis 2 2
Anemia 1 1
Ossification 1 1
Pulmonary Embolism 1 1
Abdominal Pain 1 1
Abscess 1 1
Low Blood Pressure/ Hypotension 1 1
Fever 1 1
Cyst(s) 1 1
Purulent Discharge 1 1
Nerve Damage 1 1
Arthralgia 1 1
Non-union Bone Fracture 1 1
Reaction 1 1
Swelling 1 1
Tissue Breakdown 1 1
Localized Skin Lesion 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
6 Zimmer Biomet, Inc. II Nov-22-2019
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