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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
2019
189
189
2020
179
179
2021
157
157
2022
128
128
2023
190
190
2024
60
80
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
304
324
Appropriate Term/Code Not Available
148
148
Loosening of Implant Not Related to Bone-Ingrowth
131
151
Fracture
88
88
Loose or Intermittent Connection
78
78
Insufficient Information
73
73
Naturally Worn
53
53
Device Dislodged or Dislocated
38
38
Detachment of Device or Device Component
28
28
Unstable
21
21
Migration
20
20
Break
18
18
Loss of or Failure to Bond
14
14
Migration or Expulsion of Device
12
12
Malposition of Device
9
9
Loss of Osseointegration
7
7
Difficult to Insert
7
7
No Apparent Adverse Event
7
7
Patient Device Interaction Problem
6
6
Use of Device Problem
5
5
Inadequacy of Device Shape and/or Size
4
4
Device Slipped
4
4
Unintended Movement
4
4
Material Integrity Problem
3
3
Osseointegration Problem
3
3
Material Erosion
3
3
Degraded
3
3
Positioning Failure
2
2
Peeled/Delaminated
2
2
Improper or Incorrect Procedure or Method
2
2
Expulsion
2
2
Packaging Problem
2
2
Material Protrusion/Extrusion
2
2
Mechanical Jam
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Noise, Audible
2
2
Unclear Information
1
1
Positioning Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Device Damaged by Another Device
1
1
Difficult to Open or Close
1
1
Structural Problem
1
1
Patient-Device Incompatibility
1
1
Deformation Due to Compressive Stress
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Tear, Rip or Hole in Device Packaging
1
1
Leak/Splash
1
1
Off-Label Use
1
1
Device Appears to Trigger Rejection
1
1
Material Separation
1
1
Misconnection
1
1
Delivered as Unsterile Product
1
1
Corroded
1
1
Crack
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
158
158
Unspecified Infection
157
177
Insufficient Information
116
116
Pain
114
114
Joint Laxity
83
83
Bone Fracture(s)
76
76
No Information
62
62
No Known Impact Or Consequence To Patient
46
46
Loss of Range of Motion
38
38
No Code Available
33
33
Joint Dislocation
28
28
No Clinical Signs, Symptoms or Conditions
22
22
Fall
20
20
Osteopenia/ Osteoporosis
14
14
Implant Pain
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Peripheral Nervous Injury
11
31
Osteolysis
11
11
Injury
11
11
Reaction
10
10
Wound Dehiscence
9
9
Ossification
8
8
No Consequences Or Impact To Patient
8
8
Inadequate Osseointegration
8
8
Metal Related Pathology
8
8
Swelling/ Edema
7
7
Limited Mobility Of The Implanted Joint
7
7
Tissue Damage
7
7
Nerve Damage
7
7
Impaired Healing
6
6
Numbness
6
6
Limb Fracture
6
6
Cramp(s) /Muscle Spasm(s)
5
5
Patient Problem/Medical Problem
5
5
Post Operative Wound Infection
5
5
Fracture, Arm
5
5
Tissue Breakdown
5
5
Scar Tissue
5
5
Synovitis
5
5
Adhesion(s)
5
5
Inflammation
5
5
Malunion of Bone
5
5
Fistula
4
4
Discomfort
4
4
Swelling
4
4
Hypersensitivity/Allergic reaction
4
4
Blood Loss
4
4
Peroneal Nerve Palsy
4
4
Disability
4
4
Muscle/Tendon Damage
4
4
Foreign Body In Patient
3
3
Hematoma
3
3
Muscle Weakness
3
3
Anemia
3
3
Arthritis
3
3
Bacterial Infection
3
3
Rheumatoid Arthritis
2
2
Necrosis
2
2
Local Reaction
2
2
Perforation
2
2
Seroma
2
2
Unequal Limb Length
2
2
Device Embedded In Tissue or Plaque
2
2
Joint Contracture
2
2
Non-union Bone Fracture
2
2
No Patient Involvement
2
2
Decreased Sensitivity
2
2
Fluid Discharge
1
1
Arthralgia
1
1
Ambulation Difficulties
1
1
Pneumothorax
1
1
Paralysis
1
1
Erosion
1
1
Cyst(s)
1
1
Debris, Bone Shedding
1
1
Muscular Rigidity
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
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