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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 36 36
2022 116 116
2023 143 143
2024 72 72

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 267 267
Insufficient Information 206 206
Unstable 104 104
Break 80 80
Device Dislodged or Dislocated 59 59
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Migration or Expulsion of Device 28 28
Fracture 23 23
Appropriate Term/Code Not Available 21 21
Device-Device Incompatibility 21 21
Detachment of Device or Device Component 20 20
Noise, Audible 18 18
Packaging Problem 14 14
Naturally Worn 13 13
Patient Device Interaction Problem 11 11
Malposition of Device 11 11
Inadequacy of Device Shape and/or Size 11 11
Migration 9 9
Material Erosion 8 8
Detachment Of Device Component 7 7
Material Deformation 7 7
Defective Device 6 6
Difficult to Remove 6 6
Improper or Incorrect Procedure or Method 6 6
Mechanical Problem 5 5
Difficult to Insert 5 5
Unintended Movement 5 5
Scratched Material 4 4
Loss of or Failure to Bond 4 4
Loss of Osseointegration 4 4
Material Separation 3 3
Loose or Intermittent Connection 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Markings/Labelling Problem 3 3
Device Operates Differently Than Expected 2 2
Off-Label Use 2 2
Device Packaging Compromised 2 2
Osseointegration Problem 2 2
Torn Material 2 2
Positioning Problem 2 2
Device Slipped 2 2
Separation Failure 2 2
Component Missing 2 2
Tear, Rip or Hole in Device Packaging 1 1
Metal Shedding Debris 1 1
Failure to Cut 1 1
Failure to Advance 1 1
Shipping Damage or Problem 1 1
Material Too Rigid or Stiff 1 1
Delivered as Unsterile Product 1 1
Difficult To Position 1 1
Incorrect Measurement 1 1
Failure To Adhere Or Bond 1 1
Material Fragmentation 1 1
Component Incompatible 1 1
Corroded 1 1
Positioning Failure 1 1
Disassembly 1 1
Disconnection 1 1
Material Disintegration 1 1
No Apparent Adverse Event 1 1
Incorrect Device Or Component Shipped 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Patient-Device Incompatibility 1 1
Device Damaged by Another Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 309 309
No Clinical Signs, Symptoms or Conditions 106 106
No Code Available 74 74
No Information 67 67
Limited Mobility Of The Implanted Joint 66 66
Insufficient Information 60 60
Failure of Implant 56 56
Loss of Range of Motion 55 55
Unspecified Infection 52 52
Joint Dislocation 50 50
Tissue Damage 36 36
Bone Fracture(s) 35 35
Unspecified Tissue Injury 26 26
Muscle/Tendon Damage 26 26
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
Erosion 12 12
Discomfort 11 11
Reaction 10 10
Fall 9 9
Muscular Rigidity 9 9
Fluid Discharge 8 8
Osteopenia/ Osteoporosis 7 7
Metal Related Pathology 7 7
Wound Dehiscence 7 7
Synovitis 7 7
Post Operative Wound Infection 7 7
Scar Tissue 7 7
Nerve Damage 7 7
Tingling 6 6
Osteolysis 6 6
Inflammation 6 6
No Patient Involvement 6 6
Foreign Body In Patient 6 6
Patient Problem/Medical Problem 5 5
Ossification 5 5
Adhesion(s) 5 5
Bradycardia 4 4
Arthritis 4 4
Foreign Body Reaction 4 4
Fracture, Arm 4 4
Swelling 4 4
Implant Pain 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Thrombosis/Thrombus 3 3
Neuropathy 3 3
Myalgia 3 3
Stenosis 3 3
Hypersensitivity/Allergic reaction 3 3
Damage to Ligament(s) 3 3
Muscle Weakness 3 3
Necrosis 3 3
Edema 3 3
Erythema 3 3
Cervical Changes 3 3
Syncope 3 3
Cyst(s) 2 2
Rheumatoid Arthritis 2 2
Muscle Spasm(s) 2 2
Headache 2 2
Abscess 2 2
Rupture 2 2
Joint Swelling 2 2
Non-union Bone Fracture 2 2
Inadequate Osseointegration 2 2
Blood Loss 2 2
Swelling/ Edema 2 2
Tissue Breakdown 1 1
Fibrosis 1 1
Not Applicable 1 1
Localized Skin Lesion 1 1
Joint Disorder 1 1
Sedation 1 1
Arthralgia 1 1
Toxicity 1 1
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Dizziness 1 1
Paralysis 1 1
Rash 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Myocardial Infarction 1 1
Bacterial Infection 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

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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