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TPLC
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show TPLC since
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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
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
115
115
2023
143
143
2024
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
244
244
Insufficient Information
205
205
Unstable
104
104
Break
72
72
Device Dislodged or Dislocated
54
54
Loosening of Implant Not Related to Bone-Ingrowth
34
34
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
Noise, Audible
17
17
Device-Device Incompatibility
16
16
Packaging Problem
14
14
Naturally Worn
11
11
Malposition of Device
11
11
Inadequacy of Device Shape and/or Size
11
11
Patient Device Interaction Problem
9
9
Migration
9
9
Material Erosion
8
8
Detachment Of Device Component
7
7
Difficult to Remove
6
6
Improper or Incorrect Procedure or Method
6
6
Defective Device
6
6
Unintended Movement
5
5
Scratched Material
4
4
Loss of Osseointegration
4
4
Mechanical Problem
4
4
Difficult to Insert
4
4
Loose or Intermittent Connection
3
3
Loss of or Failure to Bond
3
3
Device Markings/Labelling Problem
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Deformation
3
3
Device Operates Differently Than Expected
2
2
Device Packaging Compromised
2
2
Torn Material
2
2
Positioning Problem
2
2
Off-Label Use
2
2
Separation Failure
2
2
Component Missing
2
2
Device Slipped
2
2
Material Separation
2
2
Shipping Damage or Problem
1
1
Material Too Rigid or Stiff
1
1
Delivered as Unsterile Product
1
1
Difficult To Position
1
1
Tear, Rip or Hole in Device Packaging
1
1
Metal Shedding Debris
1
1
Failure to Advance
1
1
Failure To Adhere Or Bond
1
1
Material Fragmentation
1
1
Incorrect Measurement
1
1
Component Incompatible
1
1
Corroded
1
1
Positioning Failure
1
1
Disassembly
1
1
Disconnection
1
1
Material Disintegration
1
1
Osseointegration Problem
1
1
Patient-Device Incompatibility
1
1
Device Damaged by Another Device
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Mechanical Jam
1
1
Incorrect Device Or Component Shipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
298
298
No Clinical Signs, Symptoms or Conditions
91
91
No Code Available
74
74
No Information
67
67
Limited Mobility Of The Implanted Joint
66
66
Failure of Implant
55
55
Unspecified Infection
52
52
Loss of Range of Motion
51
51
Insufficient Information
46
46
Joint Dislocation
43
43
Tissue Damage
36
36
Bone Fracture(s)
32
32
Unspecified Tissue Injury
23
23
Muscle/Tendon Damage
21
21
Hematoma
20
20
Joint Laxity
19
19
Subluxation
17
17
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
Reaction
10
10
Erosion
10
10
Muscular Rigidity
9
9
Fall
8
8
Fluid Discharge
8
8
Metal Related Pathology
7
7
Nerve Damage
7
7
Wound Dehiscence
7
7
Post Operative Wound Infection
7
7
Synovitis
7
7
Scar Tissue
6
6
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
Osteopenia/ Osteoporosis
4
4
Implant Pain
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
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
Fibrosis
1
1
Not Applicable
1
1
Inadequate Osseointegration
1
1
Tissue Breakdown
1
1
Swelling/ Edema
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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