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TPLC
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Device
prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Product Code
KRO
Regulation Number
888.3510
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEPUY (IRELAND)
SUBSTANTIALLY EQUIVALENT
1
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
2
LINK BIO CORP.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
MICROPORT ORTHOPEDICS INC.
SUBSTANTIALLY EQUIVALENT
2
ONKOS SURGICAL
SUBSTANTIALLY EQUIVALENT
1
STRYKER
SUBSTANTIALLY EQUIVALENT
1
UNITED ORTHOPEDIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
WALDEMAR LINK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
2
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
759
759
2020
749
749
2021
767
767
2022
893
893
2023
746
746
2024
399
399
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1703
1703
Insufficient Information
580
580
Fracture
449
449
Loss of Osseointegration
247
247
Loosening of Implant Not Related to Bone-Ingrowth
212
212
Device Dislodged or Dislocated
185
185
Unstable
171
171
Detachment of Device or Device Component
169
169
Naturally Worn
142
142
Appropriate Term/Code Not Available
133
133
Break
88
88
Patient Device Interaction Problem
78
78
Device Appears to Trigger Rejection
71
71
Loose or Intermittent Connection
57
57
Degraded
54
54
Failure to Advance
49
49
Mechanical Problem
46
46
Patient-Device Incompatibility
40
40
Migration
40
40
Osseointegration Problem
38
38
Unintended Movement
36
36
Compatibility Problem
26
26
Malposition of Device
19
19
Separation Failure
18
18
Use of Device Problem
17
17
Inadequacy of Device Shape and/or Size
17
17
Material Erosion
16
16
Packaging Problem
16
16
Mechanical Jam
15
15
Noise, Audible
14
14
Delivered as Unsterile Product
14
14
Improper or Incorrect Procedure or Method
13
13
Component Missing
12
12
Tear, Rip or Hole in Device Packaging
12
12
Material Fragmentation
12
12
No Apparent Adverse Event
12
12
Material Deformation
11
11
Loss of or Failure to Bond
11
11
Migration or Expulsion of Device
11
11
Shipping Damage or Problem
11
11
Crack
10
10
Material Integrity Problem
9
9
Connection Problem
9
9
Manufacturing, Packaging or Shipping Problem
9
9
Activation Failure
9
9
Corroded
8
8
Unsealed Device Packaging
8
8
Off-Label Use
7
7
Positioning Failure
7
7
Failure to Osseointegrate
7
7
Expiration Date Error
5
5
Contamination /Decontamination Problem
5
5
Device Damaged by Another Device
5
5
Device-Device Incompatibility
5
5
Positioning Problem
5
5
Device Contaminated During Manufacture or Shipping
5
5
Human-Device Interface Problem
4
4
Device Difficult to Maintain
4
4
Biocompatibility
4
4
Collapse
4
4
Component Incompatible
4
4
Material Disintegration
3
3
Difficult to Insert
3
3
No Device Output
3
3
Material Rupture
3
3
Material Separation
3
3
Fitting Problem
3
3
Sharp Edges
3
3
Material Twisted/Bent
3
3
Difficult or Delayed Separation
3
3
Physical Resistance/Sticking
2
2
Separation Problem
2
2
Unclear Information
2
2
Operating System Becomes Nonfunctional
2
2
Device Damaged Prior to Use
2
2
Defective Component
2
2
Microbial Contamination of Device
2
2
Failure to Align
2
2
Device Difficult to Setup or Prepare
2
2
Device Slipped
2
2
Defective Device
2
2
Product Quality Problem
2
2
Misassembled
2
2
Nonstandard Device
2
2
Difficult or Delayed Positioning
2
2
Contamination
1
1
Labelling, Instructions for Use or Training Problem
1
1
Material Frayed
1
1
Material Discolored
1
1
Incorrect Measurement
1
1
Misconnection
1
1
Difficult to Remove
1
1
Peeled/Delaminated
1
1
Failure to Power Up
1
1
Ambient Noise Problem
1
1
Difficult or Delayed Activation
1
1
Dent in Material
1
1
Component or Accessory Incompatibility
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
1225
1225
Insufficient Information
701
701
Pain
496
496
Failure of Implant
454
454
Injury
360
360
Inadequate Osseointegration
220
220
No Clinical Signs, Symptoms or Conditions
195
195
Joint Laxity
177
177
No Code Available
174
174
Ambulation Difficulties
155
155
No Information
151
151
Bone Fracture(s)
136
136
Fall
135
135
Joint Dislocation
125
125
Cancer
118
118
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
78
78
Loss of Range of Motion
78
78
No Known Impact Or Consequence To Patient
66
67
Scar Tissue
58
58
Unequal Limb Length
54
54
Patient Problem/Medical Problem
48
48
Swelling
42
42
Inflammation
42
42
Swelling/ Edema
39
39
Metal Related Pathology
38
38
Implant Pain
30
30
Joint Disorder
30
30
Limited Mobility Of The Implanted Joint
26
26
Unspecified Tissue Injury
24
24
Death
23
23
Adhesion(s)
22
22
Hematoma
21
21
Bacterial Infection
19
19
Post Operative Wound Infection
19
19
Reaction
18
18
Wound Dehiscence
18
18
Fluid Discharge
17
17
Foreign Body Reaction
16
16
Hypersensitivity/Allergic reaction
15
15
Muscular Rigidity
14
14
No Consequences Or Impact To Patient
14
14
Muscle/Tendon Damage
14
14
Synovitis
13
13
Hyperextension
12
12
Osteolysis
11
11
Post Traumatic Wound Infection
10
10
Ulcer
10
10
Necrosis
10
10
Osteopenia/ Osteoporosis
10
10
Damage to Ligament(s)
9
9
Discomfort
9
9
Tissue Damage
9
9
Hemorrhage/Bleeding
8
8
Ossification
8
8
Edema
8
8
No Patient Involvement
8
8
Joint Contracture
8
8
Not Applicable
7
7
Skin Discoloration
7
7
Blood Loss
5
5
Foreign Body In Patient
4
4
Subluxation
4
4
Thrombosis
4
4
Staphylococcus Aureus
4
4
Impaired Healing
4
4
Sepsis
4
4
Hypovolemia
4
4
Hip Fracture
4
4
Arthralgia
4
4
Joint Swelling
3
3
Numbness
3
3
Rupture
3
3
Anemia
3
3
Ischemia
3
3
Unspecified Musculoskeletal problem
3
3
Limb Fracture
3
3
Physical Asymmetry
3
3
Fibrosis
3
3
Device Embedded In Tissue or Plaque
2
2
Weight Changes
2
2
Bone Shedding Debris
2
2
Stroke/CVA
2
2
Erythema
2
2
Fever
2
2
Abdominal Pain
2
2
Abscess
2
2
Discharge
2
2
Scarring
2
2
Rash
2
2
Fungal Infection
2
2
Toxicity
2
2
Non-union Bone Fracture
1
1
Distress
1
1
Local Reaction
1
1
Renal Failure
1
1
Weakness
1
1
Skin Erosion
1
1
Host-Tissue Reaction
1
1
Erosion
1
1
Calcium Deposits/Calcification
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Mar-17-2023
2
Linkbio Corp.
II
May-04-2023
3
United Orthopedic Corporation
II
Feb-29-2024
4
Uoc Usa Inc
II
Oct-14-2021
5
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Jun-30-2023
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