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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
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 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
IGNITE ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 4
SHOULDER INNOVATIONS INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 193 193
2018 99 99
2019 46 46
2020 24 24
2021 35 35
2022 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 155 155
Insufficient Information 120 120
Unstable 81 81
Device Dislodged or Dislocated 40 40
Loosening of Implant Not Related to Bone-Ingrowth 31 31
Migration or Expulsion of Device 23 23
Break 22 22
Appropriate Term/Code Not Available 17 17
Detachment of Device or Device Component 15 15
Packaging Problem 14 14
Fracture 14 14
Noise, Audible 8 8
Material Erosion 7 7
Migration 7 7
Naturally Worn 6 6
Malposition of Device 5 5
Improper or Incorrect Procedure or Method 5 5
Difficult to Remove 5 5
Patient Device Interaction Problem 5 5
Unintended Movement 4 4
Detachment Of Device Component 3 3
Inadequacy of Device Shape and/or Size 3 3
Loss of Osseointegration 3 3
Device Markings/Labelling Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Insert 2 2
Loose or Intermittent Connection 2 2
Positioning Problem 2 2
Defective Device 2 2
Separation Failure 2 2
Device Packaging Compromised 2 2
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Device Damaged by Another Device 1 1
Material Separation 1 1
Off-Label Use 1 1
Material Fragmentation 1 1
Positioning Failure 1 1
Material Disintegration 1 1
Failure to Advance 1 1
Incorrect Device Or Component Shipped 1 1
Material Deformation 1 1
Osseointegration Problem 1 1
Failure To Adhere Or Bond 1 1
Corroded 1 1
Tear, Rip or Hole in Device Packaging 1 1
Disassembly 1 1
Incorrect Measurement 1 1
Difficult To Position 1 1
Shipping Damage or Problem 1 1
Device Slipped 1 1
Component Missing 1 1
Scratched Material 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 212 212
Limited Mobility Of The Implanted Joint 53 53
No Code Available 51 51
Failure of Implant 45 45
No Information 44 44
Loss of Range of Motion 44 44
Tissue Damage 32 32
Joint Dislocation 31 31
Unspecified Infection 26 26
No Clinical Signs, Symptoms or Conditions 25 25
Bone Fracture(s) 24 24
Insufficient Information 22 22
Muscle/Tendon Damage 16 16
Numbness 14 14
No Known Impact Or Consequence To Patient 13 13
Subluxation 10 10
No Consequences Or Impact To Patient 9 9
Reaction 9 9
Post Operative Wound Infection 7 7
Wound Dehiscence 7 7
Erosion 7 7
Fall 6 6
Hematoma 6 6
Osteolysis 6 6
Tingling 6 6
Metal Related Pathology 6 6
No Patient Involvement 6 6
Weakness 6 6
Nerve Damage 6 6
Scar Tissue 5 5
Ossification 5 5
Discomfort 5 5
Foreign Body In Patient 5 5
Muscular Rigidity 5 5
Inflammation 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Patient Problem/Medical Problem 4 4
Joint Laxity 4 4
Necrosis 3 3
Myalgia 3 3
Damage to Ligament(s) 3 3
Bradycardia 3 3
Edema 3 3
Thrombosis/Thrombus 3 3
Cervical Changes 3 3
Stenosis 3 3
Syncope 3 3
Adhesion(s) 3 3
Erythema 3 3
Neuropathy 3 3
Muscle Weakness 2 2
Abscess 2 2
Ambulation Difficulties 2 2
Osteopenia/ Osteoporosis 2 2
Fracture, Arm 2 2
Synovitis 2 2
Headache 2 2
Blood Loss 2 2
Muscle Spasm(s) 2 2
Hypersensitivity/Allergic reaction 2 2
Foreign Body Reaction 2 2
Abdominal Pain 1 1
Bacterial Infection 1 1
Myocardial Infarction 1 1
Arthralgia 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Not Applicable 1 1
Implant Pain 1 1
Swelling/ Edema 1 1
Low Blood Pressure/ Hypotension 1 1
Cyst(s) 1 1
Swelling 1 1
Pulmonary Embolism 1 1
Inadequate Osseointegration 1 1
Tissue Breakdown 1 1
Purulent Discharge 1 1
Sleep Dysfunction 1 1
Anemia 1 1
Rheumatoid Arthritis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Feb-24-2022
2 Biomet, Inc. II Mar-03-2020
3 Zimmer Biomet, Inc. II Nov-22-2019
4 Zimmer Biomet, Inc. II Dec-07-2018
5 Zimmer Biomet, Inc. II Dec-29-2017
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