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TPLC
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Device
prosthesis, elbow, constrained, cemented
Product Code
JDC
Regulation Number
888.3150
Device Class
2
Premarket Reviews
Manufacturer
Decision
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
1
ZIMMER INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
244
244
2019
189
189
2020
179
179
2021
157
157
2022
128
128
2023
150
150
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
256
256
Appropriate Term/Code Not Available
162
162
Insufficient Information
140
140
Loosening of Implant Not Related to Bone-Ingrowth
107
107
Loose or Intermittent Connection
103
103
Fracture
102
102
Naturally Worn
71
71
Device Dislodged or Dislocated
50
50
Migration or Expulsion of Device
31
31
Migration
30
30
Detachment of Device or Device Component
28
28
Break
19
19
Unstable
17
17
Malposition of Device
17
17
Loss of or Failure to Bond
14
14
Difficult to Insert
12
12
Loss of Osseointegration
7
7
Device Slipped
7
7
No Apparent Adverse Event
7
7
Patient Device Interaction Problem
5
5
Unintended Movement
4
4
Inadequacy of Device Shape and/or Size
4
4
Use of Device Problem
4
4
Material Erosion
4
4
Disassembly
3
3
Degraded
3
3
Metal Shedding Debris
3
3
Misconnection
3
3
Mechanical Jam
3
3
Osseointegration Problem
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Integrity Problem
3
3
Noise, Audible
3
3
Physical Resistance/Sticking
2
2
Material Protrusion/Extrusion
2
2
Expulsion
2
2
Device Contaminated During Manufacture or Shipping
2
2
Device Operates Differently Than Expected
2
2
Packaging Problem
2
2
Positioning Problem
2
2
Difficult to Advance
2
2
Peeled/Delaminated
2
2
Positioning Failure
2
2
Contamination
2
2
Mechanical Problem
2
2
Leak/Splash
1
1
Material Fragmentation
1
1
Corroded
1
1
Crack
1
1
Difficult or Delayed Positioning
1
1
Off-Label Use
1
1
Device Appears to Trigger Rejection
1
1
Difficult to Remove
1
1
Material Separation
1
1
Delivered as Unsterile Product
1
1
Improper or Incorrect Procedure or Method
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Tear, Rip or Hole in Device Packaging
1
1
Structural Problem
1
1
Failure to Advance
1
1
Separation Failure
1
1
Device Damaged by Another Device
1
1
Patient-Device Incompatibility
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
165
165
Unspecified Infection
165
165
Pain
133
133
No Information
110
110
Insufficient Information
101
101
No Code Available
93
93
Bone Fracture(s)
83
83
Joint Laxity
58
58
No Known Impact Or Consequence To Patient
52
52
Loss of Range of Motion
37
37
Joint Dislocation
28
28
No Clinical Signs, Symptoms or Conditions
21
21
Fall
20
20
Reaction
15
15
Osteolysis
14
14
Osteopenia/ Osteoporosis
13
13
Ambulation Difficulties
12
12
Injury
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Tissue Damage
11
11
No Consequences Or Impact To Patient
10
10
Sleep Dysfunction
9
9
Wound Dehiscence
9
9
Ossification
9
9
Hematoma
8
8
Inadequate Osseointegration
8
8
Metal Related Pathology
8
8
Limited Mobility Of The Implanted Joint
7
7
Swelling
7
7
Nerve Damage
7
7
Death
6
6
Fracture, Arm
6
6
Peroneal Nerve Palsy
6
6
Impaired Healing
6
6
Numbness
6
6
Peripheral Nervous Injury
6
6
Device Embedded In Tissue or Plaque
6
6
Implant Pain
6
6
Swelling/ Edema
6
6
Patient Problem/Medical Problem
5
5
Malunion of Bone
5
5
Discomfort
5
5
Tissue Breakdown
5
5
Tingling
5
5
Adhesion(s)
5
5
Inflammation
5
5
Scar Tissue
5
5
Neuropathy
4
4
Fistula
4
4
Synovitis
4
4
Disability
4
4
Limb Fracture
4
4
Foreign Body In Patient
4
4
Blood Loss
4
4
Post Operative Wound Infection
3
3
Necrosis
3
3
Anemia
3
3
Arthritis
3
3
Bacterial Infection
3
3
Cellulitis
3
3
Fever
3
3
Muscle/Tendon Damage
3
3
Joint Contracture
2
2
Hypersensitivity/Allergic reaction
2
2
Rheumatoid Arthritis
2
2
Myocardial Infarction
2
2
Local Reaction
2
2
Perforation
2
2
Seroma
2
2
Peritonitis
2
2
Non-union Bone Fracture
2
2
Decreased Sensitivity
2
2
No Patient Involvement
2
2
Fluid Discharge
1
1
Arthralgia
1
1
Joint Disorder
1
1
Pneumothorax
1
1
Paralysis
1
1
Sepsis
1
1
Muscular Rigidity
1
1
Atrial Fibrillation
1
1
Erosion
1
1
Pulmonary Embolism
1
1
Cyst(s)
1
1
Debris, Bone Shedding
1
1
Erythema
1
1
Not Applicable
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Limacorporate S.p.A
II
Mar-16-2023
2
Zimmer Biomet, Inc.
II
Feb-05-2020
3
Zimmer Biomet, Inc.
II
Nov-07-2019
4
Zimmer Biomet, Inc.
II
Mar-14-2018
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