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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
IGNITE ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
SHOULDER INNOVATIONS INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 130 130
Insufficient Information 51 51
Loosening of Implant Not Related to Bone-Ingrowth 31 31
Device Dislodged or Dislocated 24 24
Break 22 22
Unstable 18 18
Detachment of Device or Device Component 14 14
Fracture 13 13
Migration or Expulsion of Device 8 8
Packaging Problem 7 7
Migration 7 7
Appropriate Term/Code Not Available 7 7
Naturally Worn 6 6
Material Erosion 5 5
Patient Device Interaction Problem 5 5
Unintended Movement 4 4
Noise, Audible 4 4
Malposition of Device 4 4
Loss of Osseointegration 3 3
Loose or Intermittent Connection 2 2
Defective Device 2 2
Device Markings/Labelling Problem 2 2
Positioning Problem 2 2
Detachment Of Device Component 2 2
Improper or Incorrect Procedure or Method 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 1 1
Tear, Rip or Hole in Device Packaging 1 1
Difficult To Position 1 1
Difficult to Remove 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Corroded 1 1
Positioning Failure 1 1
Disassembly 1 1
Material Disintegration 1 1
Failure To Adhere Or Bond 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Osseointegration Problem 1 1
Device Packaging Compromised 1 1
Failure to Advance 1 1
Separation Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 101 101
Failure of Implant 44 44
Loss of Range of Motion 29 29
No Information 27 27
No Clinical Signs, Symptoms or Conditions 25 25
Insufficient Information 22 22
Limited Mobility Of The Implanted Joint 22 22
Unspecified Infection 20 20
Joint Dislocation 18 18
Bone Fracture(s) 16 16
Muscle/Tendon Damage 15 15
No Code Available 14 14
Tissue Damage 14 14
Subluxation 9 9
Numbness 6 6
Metal Related Pathology 6 6
Osteolysis 6 6
Hematoma 6 6
Erosion 6 6
Wound Dehiscence 5 5
Reaction 5 5
Inflammation 5 5
Scar Tissue 5 5
Post Operative Wound Infection 5 5
Foreign Body In Patient 5 5
No Known Impact Or Consequence To Patient 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Joint Laxity 3 3
Thrombosis/Thrombus 3 3
No Patient Involvement 3 3
Damage to Ligament(s) 3 3
Nerve Damage 3 3
Syncope 3 3
Adhesion(s) 3 3
Bradycardia 3 3
Fall 3 3
Abscess 2 2
Hypersensitivity/Allergic reaction 2 2
Synovitis 2 2
No Consequences Or Impact To Patient 2 2
Fracture, Arm 2 2
Muscular Rigidity 2 2
Ambulation Difficulties 2 2
Blood Loss 2 2
Osteopenia/ Osteoporosis 2 2
Implant Pain 1 1
Swelling/ Edema 1 1
Sleep Dysfunction 1 1
Inadequate Osseointegration 1 1
Tissue Breakdown 1 1
Not Applicable 1 1
Patient Problem/Medical Problem 1 1
Swelling 1 1
Arthralgia 1 1
Non-union Bone Fracture 1 1
Discomfort 1 1
Low Blood Pressure/ Hypotension 1 1
Purulent Discharge 1 1
Anemia 1 1
Rheumatoid Arthritis 1 1
Bacterial Infection 1 1
Abdominal Pain 1 1
Ossification 1 1
Pulmonary Embolism 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
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