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TPLC
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Device
prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
Product Code
HRY
Regulation Number
888.3530
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
NANOORTHO, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
367
367
2020
1055
1055
2021
1219
1219
2022
842
842
2023
401
401
2024
99
99
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1434
1434
Fracture
489
489
Adverse Event Without Identified Device or Use Problem
373
373
Loosening of Implant Not Related to Bone-Ingrowth
208
208
Insufficient Information
205
205
Naturally Worn
144
144
Crack
141
141
Detachment of Device or Device Component
129
129
Unstable
127
127
Loose or Intermittent Connection
80
80
Material Deformation
69
69
Connection Problem
64
64
Loss of Osseointegration
56
56
Appropriate Term/Code Not Available
53
53
Device Dislodged or Dislocated
46
46
Positioning Failure
44
44
Material Fragmentation
41
41
Component Missing
40
40
Defective Device
39
39
Mechanical Jam
39
39
Dull, Blunt
37
37
Mechanical Problem
37
37
Difficult to Insert
30
30
Material Separation
28
28
Migration
28
28
Patient Device Interaction Problem
24
24
Loss of or Failure to Bond
23
23
Incomplete or Inadequate Connection
22
22
Material Twisted/Bent
22
22
Device Contamination with Chemical or Other Material
21
21
Malposition of Device
21
21
Noise, Audible
20
20
Unintended Movement
20
20
Material Integrity Problem
16
16
Patient-Device Incompatibility
16
16
Physical Resistance/Sticking
15
15
Device Markings/Labelling Problem
14
14
Device-Device Incompatibility
14
14
Device Reprocessing Problem
12
12
Degraded
11
11
Mechanics Altered
11
11
Corroded
10
10
Contamination /Decontamination Problem
9
9
Improper or Incorrect Procedure or Method
9
9
Use of Device Problem
8
8
Flaked
8
8
Inadequacy of Device Shape and/or Size
7
7
Separation Failure
7
7
Failure to Align
7
7
Osseointegration Problem
7
7
Fitting Problem
6
6
Material Discolored
6
6
Positioning Problem
5
5
No Apparent Adverse Event
5
5
Component Misassembled
5
5
Premature Separation
5
5
Packaging Problem
4
4
Peeled/Delaminated
4
4
Misassembled
4
4
Device Damaged Prior to Use
4
4
Tear, Rip or Hole in Device Packaging
4
4
Solder Joint Fracture
4
4
Failure to Disconnect
4
4
Biocompatibility
3
3
Structural Problem
3
3
Shipping Damage or Problem
3
3
Difficult to Remove
3
3
Material Too Rigid or Stiff
3
3
Nonstandard Device
3
3
Delivered as Unsterile Product
3
3
Off-Label Use
3
3
Scratched Material
3
3
Material Split, Cut or Torn
3
3
Device Fell
2
2
Difficult or Delayed Separation
2
2
No Fail-Safe Mechanism
2
2
Device Contaminated During Manufacture or Shipping
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Puncture/Hole
2
2
Device Appears to Trigger Rejection
2
2
Unsealed Device Packaging
2
2
Material Erosion
2
2
Failure to Charge
2
2
Device Slipped
2
2
Unexpected Therapeutic Results
2
2
Failure to Osseointegrate
2
2
Activation, Positioning or Separation Problem
2
2
Device Damaged by Another Device
2
2
Deformation Due to Compressive Stress
1
1
Failure to Calibrate
1
1
Residue After Decontamination
1
1
Suction Problem
1
1
Burst Container or Vessel
1
1
Complete Blockage
1
1
Insufficient Heating
1
1
Disconnection
1
1
Failure to Disinfect
1
1
Material Disintegration
1
1
Entrapment of Device
1
1
Migration or Expulsion of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2265
2265
Pain
347
347
No Known Impact Or Consequence To Patient
200
200
Unspecified Infection
184
184
No Consequences Or Impact To Patient
165
165
No Patient Involvement
164
164
Insufficient Information
156
156
Failure of Implant
153
153
No Information
150
150
No Code Available
130
130
Ambulation Difficulties
98
98
Loss of Range of Motion
70
70
Swelling/ Edema
67
67
Joint Laxity
63
63
Injury
60
60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
36
36
Joint Dislocation
34
34
Bone Fracture(s)
32
32
Synovitis
27
27
Not Applicable
21
21
Foreign Body In Patient
20
20
Osteolysis
20
20
Swelling
17
17
Inadequate Osseointegration
17
17
Muscular Rigidity
16
16
Inflammation
14
14
Adhesion(s)
13
13
Scar Tissue
13
13
Discomfort
12
12
Fall
12
12
Hypersensitivity/Allergic reaction
12
12
Arthritis
10
10
Metal Related Pathology
10
10
Joint Disorder
9
9
Post Operative Wound Infection
8
8
Limited Mobility Of The Implanted Joint
7
7
Device Embedded In Tissue or Plaque
7
7
Reaction
7
7
Thrombosis/Thrombus
6
6
Ossification
6
6
Fatigue
6
6
Hemorrhage/Bleeding
6
6
Implant Pain
6
6
Unspecified Tissue Injury
5
5
Cyst(s)
5
5
Osteopenia/ Osteoporosis
5
5
Fluid Discharge
4
4
Numbness
4
4
Laceration(s)
4
4
Cellulitis
4
4
Subluxation
4
4
Unspecified Musculoskeletal problem
3
3
Perforation
3
3
Damage to Ligament(s)
3
3
Autoimmune Reaction
3
3
Bacterial Infection
3
3
Pulmonary Embolism
3
3
Arthralgia
3
3
Fibrosis
3
3
Patient Problem/Medical Problem
2
2
Inadequate Pain Relief
2
2
Sepsis
2
2
Tissue Damage
2
2
Muscle Weakness
2
2
Low Blood Pressure/ Hypotension
2
2
Renal Failure
2
2
Pocket Erosion
1
1
Necrosis
1
1
Syncope
1
1
Abdominal Pain
1
1
Abrasion
1
1
Aspiration/Inhalation
1
1
Autoimmune Disorder
1
1
Erosion
1
1
Calcium Deposits/Calcification
1
1
Edema
1
1
Embolism
1
1
Burning Sensation
1
1
Hip Fracture
1
1
Neck Stiffness
1
1
Deformity/ Disfigurement
1
1
Non-union Bone Fracture
1
1
Tissue Breakdown
1
1
Alteration In Body Temperature
1
1
Hormonal Imbalance
1
1
Breast Discomfort/Pain
1
1
Unspecified Immune System Problem
1
1
Muscle/Tendon Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Sep-22-2021
2
Biomet, Inc.
II
Jan-26-2023
3
Biomet, Inc.
II
Dec-17-2020
4
Biomet, Inc.
II
May-28-2020
5
Exactech, Inc.
II
Oct-04-2021
6
MicroPort Orthopedics Inc.
II
Nov-22-2022
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