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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
AESCULAP IMPLANT SYSTEMS, LLC
SUBSTANTIALLY EQUIVALENT
1
BIOMET MANUFACTURING CORP.
SUBSTANTIALLY EQUIVALENT
1
BIOMET UK LTD.
SUBSTANTIALLY EQUIVALENT
1
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
MAKO SURGICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MATERIALISE N.V.
SUBSTANTIALLY EQUIVALENT
1
MICROPORT ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
NANOORTHO, LLC
SUBSTANTIALLY EQUIVALENT
1
WRIGHT MEDICAL TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
305
305
2015
344
344
2016
343
343
2017
402
402
2018
612
612
2019
367
367
2020
1055
1055
2021
1219
1219
2022
842
842
2023
401
401
2024
125
125
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1510
1510
Insufficient Information
871
871
Naturally Worn
642
642
Fracture
543
543
Adverse Event Without Identified Device or Use Problem
465
465
Loose or Intermittent Connection
213
213
Loosening of Implant Not Related to Bone-Ingrowth
211
211
Unstable
195
195
Appropriate Term/Code Not Available
168
168
Device Dislodged or Dislocated
161
161
Crack
149
149
Detachment of Device or Device Component
133
133
Loss of or Failure to Bond
74
74
Material Deformation
72
72
Loss of Osseointegration
69
69
Connection Problem
68
68
Migration or Expulsion of Device
60
60
Malposition of Device
52
52
Difficult to Insert
49
49
Positioning Failure
44
44
Mechanical Problem
43
43
Material Fragmentation
43
43
Component Missing
42
42
Defective Device
39
39
Mechanical Jam
39
39
Dull, Blunt
37
37
Noise, Audible
32
32
Migration
29
29
Material Separation
28
28
Patient Device Interaction Problem
25
25
Material Integrity Problem
24
24
Failure to Align
23
23
Material Twisted/Bent
22
22
Device Contamination with Chemical or Other Material
22
22
Unintended Movement
22
22
Incomplete or Inadequate Connection
22
22
Device Slipped
21
21
Patient-Device Incompatibility
18
18
Device-Device Incompatibility
17
17
Device Markings/Labelling Problem
16
16
Fitting Problem
16
16
Device Contaminated During Manufacture or Shipping
15
15
Physical Resistance/Sticking
15
15
Positioning Problem
14
14
Mechanics Altered
12
12
Degraded
12
12
Device Reprocessing Problem
12
12
Use of Device Problem
11
11
Corroded
10
10
Device Operates Differently Than Expected
10
10
Contamination /Decontamination Problem
9
9
Separation Failure
9
9
Scratched Material
9
9
Disassembly
9
9
Inadequacy of Device Shape and/or Size
9
9
Improper or Incorrect Procedure or Method
9
9
Material Too Rigid or Stiff
8
8
Material Discolored
8
8
Flaked
8
8
Osseointegration Problem
8
8
Packaging Problem
7
7
Tear, Rip or Hole in Device Packaging
7
7
No Apparent Adverse Event
6
6
Component Misassembled
5
5
Premature Separation
5
5
Device Damaged Prior to Use
5
5
Detachment Of Device Component
5
5
Material Erosion
4
4
Misassembled
4
4
Solder Joint Fracture
4
4
Peeled/Delaminated
4
4
Off-Label Use
4
4
Failure to Disconnect
4
4
Device Packaging Compromised
4
4
Structural Problem
3
3
Biocompatibility
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Distortion
3
3
Material Split, Cut or Torn
3
3
Difficult to Remove
3
3
Nonstandard Device
3
3
Delivered as Unsterile Product
3
3
Shipping Damage or Problem
3
3
Metal Shedding Debris
3
3
Sticking
3
3
Device Abrasion From Instrument Or Another Object
3
3
Failure To Adhere Or Bond
3
3
Failure to Charge
2
2
Component Falling
2
2
Misconnection
2
2
Labelling, Instructions for Use or Training Problem
2
2
Entrapment of Device
2
2
Unexpected Therapeutic Results
2
2
Failure to Osseointegrate
2
2
Unsealed Device Packaging
2
2
Material Puncture/Hole
2
2
Device Appears to Trigger Rejection
2
2
Separation Problem
2
2
Difficult or Delayed Separation
2
2
Device Fell
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2280
2280
No Information
865
865
Pain
831
831
Unspecified Infection
367
367
No Known Impact Or Consequence To Patient
307
307
No Code Available
306
306
No Consequences Or Impact To Patient
230
230
Osteolysis
187
187
No Patient Involvement
170
170
Failure of Implant
158
158
Insufficient Information
157
157
Injury
131
131
Ambulation Difficulties
110
110
Bone Fracture(s)
90
90
Loss of Range of Motion
84
84
Joint Dislocation
79
79
Swelling/ Edema
70
70
Joint Laxity
63
63
Not Applicable
55
55
Swelling
38
38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
36
36
Synovitis
29
29
Fall
25
25
Discomfort
24
24
Foreign Body In Patient
24
24
Inadequate Osseointegration
22
22
Muscular Rigidity
18
18
Arthritis
17
17
Reaction
17
17
Joint Disorder
16
16
Inflammation
16
16
Post Operative Wound Infection
16
16
Limited Mobility Of The Implanted Joint
16
16
Scar Tissue
15
15
Hypersensitivity/Allergic reaction
14
14
Hemorrhage/Bleeding
13
13
Adhesion(s)
13
13
Neck Stiffness
11
11
Death
10
10
Metal Related Pathology
10
10
Device Embedded In Tissue or Plaque
7
7
Thrombosis
7
7
Joint Swelling
6
6
Fatigue
6
6
Foreign Body Reaction
6
6
Laceration(s)
6
6
Cellulitis
6
6
Ossification
6
6
Thrombosis/Thrombus
6
6
Implant Pain
6
6
Unspecified Tissue Injury
5
5
Osteopenia/ Osteoporosis
5
5
Pulmonary Embolism
5
5
Cyst(s)
5
5
Damage to Ligament(s)
5
5
Arthralgia
5
5
Tissue Damage
5
5
Numbness
4
4
Bacterial Infection
4
4
Patient Problem/Medical Problem
4
4
Fibrosis
4
4
Fluid Discharge
4
4
Subluxation
4
4
Unspecified Musculoskeletal problem
3
3
Autoimmune Reaction
3
3
Hematoma
3
3
Sepsis
3
3
Urinary Tract Infection
3
3
Burning Sensation
3
3
Perforation
3
3
Rash
2
2
Renal Failure
2
2
Necrosis
2
2
Toxicity
2
2
Impaired Healing
2
2
Inadequate Pain Relief
2
2
High Blood Pressure/ Hypertension
2
2
Low Blood Pressure/ Hypotension
2
2
Edema
2
2
Muscle Weakness
2
2
Host-Tissue Reaction
2
2
Abrasion
2
2
Erosion
2
2
Rheumatoid Arthritis
2
2
Vascular Dissection
2
2
Lead(s), Burn(s) From
1
1
Unspecified Immune System Problem
1
1
Tissue Breakdown
1
1
Alteration In Body Temperature
1
1
Hormonal Imbalance
1
1
Breast Discomfort/Pain
1
1
Muscle/Tendon Damage
1
1
Aspiration/Inhalation
1
1
Autoimmune Disorder
1
1
Syncope
1
1
Abdominal Pain
1
1
Calcium Deposits/Calcification
1
1
Nausea
1
1
Irritation
1
1
Embolism
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Sep-22-2021
2
Biomet U.K., Ltd.
II
Jun-29-2011
3
Biomet, Inc.
II
Jan-26-2023
4
Biomet, Inc.
II
Dec-17-2020
5
Biomet, Inc.
II
May-28-2020
6
Biomet, Inc.
II
Jun-15-2015
7
Biomet, Inc.
II
Jul-11-2013
8
DePuy Orthopaedics, Inc.
II
Mar-20-2018
9
Exactech, Inc.
II
Oct-04-2021
10
Materialise USA LLC
II
Jan-03-2014
11
MicroPort Orthopedics Inc.
II
Nov-22-2022
12
Stryker Howmedica Osteonics Corp.
II
Jan-12-2009
13
Zimmer Biomet, Inc.
II
Mar-27-2017
14
Zimmer Biomet, Inc.
II
Jan-06-2017
15
Zimmer, Inc.
II
Mar-20-2014
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