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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 2
BIOMET MANUFACTUTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET ORTHOPEDICS LLC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 3
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
IGNITE ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 6
SHOULDER INNOVATIONS INC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA)
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 28 28
2015 49 49
2016 85 85
2017 193 193
2018 99 99
2019 47 47
2020 24 24
2021 35 35
2022 116 116
2023 143 143
2024 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 256 256
Insufficient Information 206 206
Unstable 104 104
Break 74 74
Device Dislodged or Dislocated 55 55
Loosening of Implant Not Related to Bone-Ingrowth 35 35
Migration or Expulsion of Device 28 28
Fracture 23 23
Appropriate Term/Code Not Available 21 21
Detachment of Device or Device Component 20 20
Device-Device Incompatibility 18 18
Noise, Audible 17 17
Packaging Problem 14 14
Naturally Worn 12 12
Malposition of Device 11 11
Inadequacy of Device Shape and/or Size 11 11
Patient Device Interaction Problem 11 11
Migration 9 9
Material Erosion 8 8
Detachment Of Device Component 7 7
Defective Device 6 6
Improper or Incorrect Procedure or Method 6 6
Difficult to Remove 6 6
Material Deformation 5 5
Unintended Movement 5 5
Loss of Osseointegration 4 4
Mechanical Problem 4 4
Scratched Material 4 4
Difficult to Insert 4 4
Loss of or Failure to Bond 4 4
Loose or Intermittent Connection 3 3
Device Markings/Labelling Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Separation 3 3
Device Packaging Compromised 2 2
Separation Failure 2 2
Off-Label Use 2 2
Positioning Problem 2 2
Torn Material 2 2
Device Slipped 2 2
Component Missing 2 2
Device Operates Differently Than Expected 2 2
Osseointegration Problem 2 2
Corroded 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure To Adhere Or Bond 1 1
Failure to Advance 1 1
Material Integrity Problem 1 1
Patient-Device Incompatibility 1 1
Material Disintegration 1 1
Material Twisted/Bent 1 1
Failure to Cut 1 1
Metal Shedding Debris 1 1
Disassembly 1 1
Shipping Damage or Problem 1 1
Incorrect Measurement 1 1
Delivered as Unsterile Product 1 1
Difficult To Position 1 1
Disconnection 1 1
Positioning Failure 1 1
Material Fragmentation 1 1
Mechanical Jam 1 1
Component Incompatible 1 1
Device Damaged by Another Device 1 1
Material Too Rigid or Stiff 1 1
Incorrect Device Or Component Shipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 304 304
No Clinical Signs, Symptoms or Conditions 98 98
No Code Available 74 74
No Information 67 67
Limited Mobility Of The Implanted Joint 66 66
Failure of Implant 55 55
Loss of Range of Motion 54 54
Unspecified Infection 52 52
Insufficient Information 52 52
Joint Dislocation 44 44
Tissue Damage 36 36
Bone Fracture(s) 34 34
Unspecified Tissue Injury 26 26
Muscle/Tendon Damage 24 24
Hematoma 20 20
Subluxation 19 19
Joint Laxity 19 19
No Known Impact Or Consequence To Patient 16 16
Numbness 16 16
Weakness 12 12
No Consequences Or Impact To Patient 12 12
Discomfort 11 11
Erosion 11 11
Reaction 10 10
Muscular Rigidity 9 9
Fall 9 9
Fluid Discharge 8 8
Metal Related Pathology 7 7
Nerve Damage 7 7
Wound Dehiscence 7 7
Post Operative Wound Infection 7 7
Scar Tissue 7 7
Synovitis 7 7
Tingling 6 6
Osteolysis 6 6
No Patient Involvement 6 6
Foreign Body In Patient 5 5
Patient Problem/Medical Problem 5 5
Ossification 5 5
Inflammation 5 5
Foreign Body Reaction 4 4
Adhesion(s) 4 4
Bradycardia 4 4
Fracture, Arm 4 4
Swelling 4 4
Implant Pain 4 4
Osteopenia/ Osteoporosis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Thrombosis/Thrombus 3 3
Necrosis 3 3
Myalgia 3 3
Stenosis 3 3
Cervical Changes 3 3
Edema 3 3
Erythema 3 3
Syncope 3 3
Damage to Ligament(s) 3 3
Neuropathy 3 3
Muscle Weakness 3 3
Abscess 2 2
Hypersensitivity/Allergic reaction 2 2
Muscle Spasm(s) 2 2
Headache 2 2
Arthritis 2 2
Rheumatoid Arthritis 2 2
Rupture 2 2
Joint Swelling 2 2
Non-union Bone Fracture 2 2
Blood Loss 2 2
Inadequate Osseointegration 2 2
Tissue Breakdown 1 1
Fibrosis 1 1
Not Applicable 1 1
Swelling/ Edema 1 1
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Joint Disorder 1 1
Sedation 1 1
Arthralgia 1 1
Toxicity 1 1
Dizziness 1 1
Rash 1 1
Paralysis 1 1
Bacterial Infection 1 1
Cyst(s) 1 1
Death 1 1
Purulent Discharge 1 1
Dyspnea 1 1
Abdominal Pain 1 1
Anemia 1 1
Pulmonary Embolism 1 1
Host-Tissue Reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Myocardial Infarction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Feb-24-2022
2 Biomet, Inc. II Mar-03-2020
3 Biomet, Inc. III Jun-11-2015
4 Encore Medical, Lp II Sep-04-2009
5 Limacorporate S.p.A II Jan-12-2024
6 Limacorporate S.p.A II Jun-27-2023
7 Limacorporate S.p.A II Apr-01-2023
8 Zimmer Biomet, Inc. II Nov-22-2019
9 Zimmer Biomet, Inc. II Dec-07-2018
10 Zimmer Biomet, Inc. II Dec-29-2017
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