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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
2018
613
613
2019
367
367
2020
1055
1055
2021
1222
1222
2022
850
850
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1416
1416
Insufficient Information
377
377
Adverse Event Without Identified Device or Use Problem
373
373
Fracture
296
296
Loosening of Implant Not Related to Bone-Ingrowth
193
193
Naturally Worn
168
168
Crack
139
139
Loose or Intermittent Connection
132
132
Unstable
132
132
Appropriate Term/Code Not Available
120
120
Detachment of Device or Device Component
90
90
Device Dislodged or Dislocated
79
79
Material Deformation
68
68
Connection Problem
66
66
Loss of Osseointegration
51
51
Component Missing
41
41
Mechanical Problem
40
40
Material Fragmentation
39
39
Defective Device
39
39
Dull, Blunt
37
37
Mechanical Jam
36
36
Difficult to Insert
35
35
Migration or Expulsion of Device
30
30
Patient Device Interaction Problem
29
29
Loss of or Failure to Bond
28
28
Material Separation
28
28
Malposition of Device
27
27
Migration
26
26
Incomplete or Inadequate Connection
22
22
Noise, Audible
22
22
Unintended Movement
21
21
Material Twisted/Bent
21
21
Device Contamination with Chemical or Other Material
21
21
Device-Device Incompatibility
17
17
Material Integrity Problem
16
16
Patient-Device Incompatibility
16
16
Device Markings/Labelling Problem
14
14
Physical Resistance/Sticking
14
14
Device Reprocessing Problem
12
12
Corroded
10
10
Fitting Problem
10
10
Use of Device Problem
10
10
Mechanics Altered
10
10
Contamination /Decontamination Problem
9
9
Degraded
9
9
Positioning Failure
8
8
Flaked
8
8
Inadequacy of Device Shape and/or Size
8
8
Improper or Incorrect Procedure or Method
7
7
Failure to Align
7
7
Osseointegration Problem
7
7
Packaging Problem
6
6
Tear, Rip or Hole in Device Packaging
6
6
Material Discolored
6
6
No Apparent Adverse Event
5
5
Separation Failure
5
5
Premature Separation
5
5
Failure to Disconnect
4
4
Positioning Problem
4
4
Misassembled
4
4
Device Damaged Prior to Use
4
4
Peeled/Delaminated
4
4
Off-Label Use
4
4
Difficult to Remove
3
3
Material Too Rigid or Stiff
3
3
Shipping Damage or Problem
3
3
Biocompatibility
3
3
Structural Problem
3
3
Delivered as Unsterile Product
3
3
Scratched Material
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Split, Cut or Torn
3
3
Device Fell
2
2
Separation Problem
2
2
No Fail-Safe Mechanism
2
2
Device Damaged by Another Device
2
2
Device Packaging Compromised
2
2
Device Contaminated During Manufacture or Shipping
2
2
Activation, Positioning or Separation Problem
2
2
Nonstandard Device
2
2
Material Erosion
2
2
Failure to Charge
2
2
Partial Blockage
2
2
Failure to Osseointegrate
2
2
Device Slipped
2
2
Unexpected Therapeutic Results
2
2
Unsealed Device Packaging
2
2
Device Appears to Trigger Rejection
2
2
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Difficult To Position
1
1
Device Difficult to Setup or Prepare
1
1
Suction Problem
1
1
Metal Shedding Debris
1
1
Defective Component
1
1
Solder Joint Fracture
1
1
Residue After Decontamination
1
1
Device Issue
1
1
Failure to Calibrate
1
1
Deformation Due to Compressive Stress
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1937
1937
Pain
439
439
No Information
339
339
No Known Impact Or Consequence To Patient
229
229
Unspecified Infection
213
213
No Consequences Or Impact To Patient
201
201
No Code Available
192
192
No Patient Involvement
169
169
Failure of Implant
123
123
Insufficient Information
109
109
Ambulation Difficulties
101
101
Injury
86
86
Swelling/ Edema
66
66
Joint Laxity
61
61
Loss of Range of Motion
61
61
Joint Dislocation
56
56
Not Applicable
54
54
Bone Fracture(s)
53
53
Osteolysis
35
35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
35
35
Swelling
27
27
Synovitis
24
24
Foreign Body In Patient
21
21
Muscular Rigidity
16
16
Hypersensitivity/Allergic reaction
15
15
Inadequate Osseointegration
15
15
Inflammation
14
14
Fall
14
14
Discomfort
13
13
Adhesion(s)
12
12
Arthritis
10
10
Reaction
10
10
Post Operative Wound Infection
10
10
Joint Disorder
10
10
Limited Mobility Of The Implanted Joint
10
10
Scar Tissue
9
9
Device Embedded In Tissue or Plaque
7
7
Neck Stiffness
7
7
Death
7
7
Fatigue
6
6
Cellulitis
6
6
Hemorrhage/Bleeding
6
6
Cyst(s)
5
5
Implant Pain
5
5
Metal Related Pathology
5
5
Unspecified Tissue Injury
4
4
Fluid Discharge
4
4
Thrombosis/Thrombus
4
4
Damage to Ligament(s)
4
4
Numbness
4
4
Tissue Damage
3
3
Urinary Tract Infection
3
3
Burning Sensation
3
3
Joint Swelling
3
3
Osteopenia/ Osteoporosis
3
3
Hematoma
3
3
Laceration(s)
3
3
Ossification
3
3
Pulmonary Embolism
3
3
Autoimmune Reaction
3
3
Bacterial Infection
3
3
Unspecified Musculoskeletal problem
3
3
High Blood Pressure/ Hypertension
2
2
Low Blood Pressure/ Hypotension
2
2
Rash
2
2
Renal Failure
2
2
Patient Problem/Medical Problem
2
2
Sepsis
2
2
Scarring
1
1
Hip Fracture
1
1
Tissue Breakdown
1
1
Alteration In Body Temperature
1
1
Fibrosis
1
1
Vascular Dissection
1
1
Deformity/ Disfigurement
1
1
Non-union Bone Fracture
1
1
Perforation
1
1
Phlebitis
1
1
Muscle Weakness
1
1
Necrosis
1
1
Host-Tissue Reaction
1
1
Erosion
1
1
Calcium Deposits/Calcification
1
1
Aspiration/Inhalation
1
1
Autoimmune Disorder
1
1
Syncope
1
1
Edema
1
1
Embolism
1
1
Muscle/Tendon Damage
1
1
Hormonal Imbalance
1
1
Breast Discomfort/Pain
1
1
Subluxation
1
1
Unspecified Immune System Problem
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
DePuy Orthopaedics, Inc.
II
Mar-20-2018
6
Exactech, Inc.
II
Oct-04-2021
7
MicroPort Orthopedics Inc.
II
Nov-22-2022
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