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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
BIOMET, INC
  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 2
SHOULDER INNOVATIONS INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 193 193
2018 99 99
2019 46 46
2020 24 24
2021 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 114 114
Adverse Event Without Identified Device or Use Problem 90 90
Unstable 75 75
Device Dislodged or Dislocated 27 27
Migration or Expulsion of Device 23 23
Appropriate Term/Code Not Available 15 15
Packaging Problem 14 14
Detachment of Device or Device Component 14 14
Break 10 10
Fracture 10 10
Loosening of Implant Not Related to Bone-Ingrowth 10 10
Noise, Audible 8 8
Migration 5 5
Difficult to Remove 5 5
Malposition of Device 5 5
Naturally Worn 4 4
Unintended Movement 3 3
Patient Device Interaction Problem 3 3
Device Markings/Labelling Problem 3 3
Loss of Osseointegration 3 3
Improper or Incorrect Procedure or Method 3 3
Inadequacy of Device Shape and/or Size 3 3
Detachment Of Device Component 3 3
Material Erosion 2 2
Difficult to Insert 2 2
Separation Failure 2 2
Defective Device 2 2
Device Packaging Compromised 2 2
Positioning Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Scratched Material 1 1
Incorrect Device Or Component Shipped 1 1
Device Damaged by Another Device 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Difficult To Position 1 1
Off-Label Use 1 1
Device Slipped 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Failure To Adhere Or Bond 1 1
Material Fragmentation 1 1
Corroded 1 1
Positioning Failure 1 1
Disassembly 1 1
Disconnection 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 183 183
Limited Mobility Of The Implanted Joint 53 53
No Code Available 51 51
No Information 44 44
Loss of Range of Motion 32 32
Tissue Damage 32 32
Joint Dislocation 26 26
Failure of Implant 16 16
Unspecified Infection 15 15
Bone Fracture(s) 15 15
Numbness 14 14
No Known Impact Or Consequence To Patient 13 13
Insufficient Information 11 11
Reaction 9 9
No Consequences Or Impact To Patient 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Post Operative Wound Infection 7 7
Weakness 6 6
Tingling 6 6
No Patient Involvement 6 6
Hematoma 6 6
Nerve Damage 6 6
Muscular Rigidity 5 5
Fall 5 5
Ossification 5 5
Wound Dehiscence 4 4
Inflammation 4 4
Patient Problem/Medical Problem 4 4
Discomfort 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Myalgia 3 3
Stenosis 3 3
Scar Tissue 3 3
Neuropathy 3 3
Necrosis 3 3
Edema 3 3
Erythema 3 3
Bradycardia 3 3
Cervical Changes 3 3
Syncope 3 3
Adhesion(s) 3 3
Abscess 2 2
Erosion 2 2
Hypersensitivity/Allergic reaction 2 2
Damage to Ligament(s) 2 2
Muscle Spasm(s) 2 2
Muscle Weakness 2 2
Foreign Body Reaction 2 2
Headache 2 2
Fracture, Arm 2 2
Foreign Body In Patient 2 2
Blood Loss 2 2
Osteolysis 1 1
Osteopenia/ Osteoporosis 1 1
Tissue Breakdown 1 1
Not Applicable 1 1
Subluxation 1 1
Muscle/Tendon Damage 1 1
Swelling/ Edema 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Swelling 1 1
Low Blood Pressure/ Hypotension 1 1
Myocardial Infarction 1 1
Cyst(s) 1 1
Purulent Discharge 1 1
Anemia 1 1
Rheumatoid Arthritis 1 1
Bacterial Infection 1 1
Abdominal Pain 1 1
Pulmonary Embolism 1 1

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