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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
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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