Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Product Code
MBF
Regulation Number
888.3670
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
4
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
2023
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
136
136
Insufficient Information
51
51
Loosening of Implant Not Related to Bone-Ingrowth
31
31
Break
27
27
Device Dislodged or Dislocated
24
24
Unstable
20
20
Detachment of Device or Device Component
14
14
Fracture
14
14
Migration or Expulsion of Device
8
8
Migration
7
7
Packaging Problem
7
7
Appropriate Term/Code Not Available
7
7
Noise, Audible
6
6
Naturally Worn
6
6
Material Erosion
5
5
Patient Device Interaction Problem
5
5
Unintended Movement
4
4
Malposition of Device
4
4
Loss of Osseointegration
3
3
Device-Device Incompatibility
3
3
Improper or Incorrect Procedure or Method
2
2
Defective Device
2
2
Device Markings/Labelling Problem
2
2
Detachment Of Device Component
2
2
Difficult to Insert
2
2
Loose or Intermittent Connection
2
2
Inadequacy of Device Shape and/or Size
2
2
Positioning Problem
2
2
Device Slipped
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
Device Packaging Compromised
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Advance
1
1
Separation Failure
1
1
Osseointegration Problem
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
103
103
Failure of Implant
46
46
No Clinical Signs, Symptoms or Conditions
33
33
Loss of Range of Motion
29
29
No Information
27
27
Insufficient Information
23
23
Limited Mobility Of The Implanted Joint
22
22
Unspecified Infection
20
20
Joint Dislocation
18
18
Bone Fracture(s)
17
17
Muscle/Tendon Damage
17
17
No Code Available
14
14
Tissue Damage
14
14
Subluxation
11
11
Joint Laxity
8
8
Metal Related Pathology
6
6
Numbness
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
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
Arthritis
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
Unspecified Tissue Injury
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
Rheumatoid Arthritis
1
1
Bacterial Infection
1
1
Anemia
1
1
Abdominal Pain
1
1
Ossification
1
1
Pulmonary Embolism
1
1
Low Blood Pressure/ Hypotension
1
1
Purulent Discharge
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
-
-