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TPLC
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Device
prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Regulation Description
Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
Product Code
MBF
Regulation Number
888.3670
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMET MANUFACTURING CORP.
SUBSTANTIALLY EQUIVALENT
1
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
3
IGNITE ORTHOPEDICS LLC
SUBSTANTIALLY EQUIVALENT
1
LIMACORPORATE S.P.A
SUBSTANTIALLY EQUIVALENT
1
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
5
ZIMMER INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
24
24
2021
36
36
2022
116
116
2023
143
143
2024
165
165
2025
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
214
214
Break
96
96
Loosening of Implant Not Related to Bone-Ingrowth
46
46
Device Dislodged or Dislocated
32
32
Device-Device Incompatibility
29
29
Insufficient Information
20
20
Naturally Worn
20
20
Fracture
19
19
Patient Device Interaction Problem
12
12
Detachment of Device or Device Component
11
11
Material Deformation
10
10
Unstable
9
9
Loss of or Failure to Bond
6
6
Migration
6
6
Material Erosion
5
5
Osseointegration Problem
4
4
Defective Device
4
4
Scratched Material
4
4
Difficult to Insert
4
4
Unintended Movement
3
3
Noise, Audible
3
3
Appropriate Term/Code Not Available
3
3
Material Separation
2
2
Loose or Intermittent Connection
2
2
Loss of Osseointegration
2
2
Failure to Cut
2
2
Improper or Incorrect Procedure or Method
2
2
Device Markings/Labelling Problem
1
1
Material Fragmentation
1
1
Mechanical Problem
1
1
Material Integrity Problem
1
1
Malposition of Device
1
1
Positioning Failure
1
1
Packaging Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Component Incompatible
1
1
No Apparent Adverse Event
1
1
Failure to Advance
1
1
Delivered as Unsterile Product
1
1
Separation Failure
1
1
Difficult to Remove
1
1
Off-Label Use
1
1
Patient-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
121
121
Pain
82
82
Insufficient Information
81
81
Failure of Implant
64
64
Unspecified Tissue Injury
48
48
Joint Dislocation
27
27
Bone Fracture(s)
26
26
Muscle/Tendon Damage
25
25
Loss of Range of Motion
24
24
Unspecified Infection
23
23
Joint Laxity
20
20
Subluxation
19
19
Hematoma
13
13
Fluid Discharge
12
12
Erosion
12
12
Metal Related Pathology
12
12
Osteolysis
8
8
Thrombosis/Thrombus
7
7
Osteopenia/ Osteoporosis
7
7
Synovitis
6
6
Inflammation
6
6
Discomfort
5
5
Impaired Healing
4
4
Foreign Body In Patient
4
4
Limited Mobility Of The Implanted Joint
4
4
Inadequate Osseointegration
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Implant Pain
4
4
Arthritis
4
4
Adhesion(s)
4
4
Pulmonary Embolism
4
4
Scar Tissue
4
4
Muscular Rigidity
4
4
Hypersensitivity/Allergic reaction
3
3
Wound Dehiscence
3
3
Fall
2
2
Swelling/ Edema
2
2
Rheumatoid Arthritis
2
2
No Known Impact Or Consequence To Patient
2
2
Low Blood Pressure/ Hypotension
1
1
Localized Skin Lesion
1
1
Fever
1
1
Purulent Discharge
1
1
Cyst(s)
1
1
Abdominal Pain
1
1
Tissue Breakdown
1
1
Ossification
1
1
No Code Available
1
1
Arthralgia
1
1
Non-union Bone Fracture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Feb-24-2022
2
Biomet, Inc.
II
Mar-03-2020
3
Limacorporate S.p.A
II
Jan-12-2024
4
Limacorporate S.p.A
II
Jun-27-2023
5
Limacorporate S.p.A
II
Apr-01-2023
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