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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
LINK BIO CORP.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
2
ONKOS SURGICAL
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
2017
542
542
2018
614
614
2019
759
759
2020
749
749
2021
767
767
2022
528
528
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1244
1244
Insufficient Information
785
785
Fracture
361
361
Loss of Osseointegration
235
235
Device Dislodged or Dislocated
191
191
Unstable
161
161
Appropriate Term/Code Not Available
154
154
Break
149
149
Detachment of Device or Device Component
132
132
Loosening of Implant Not Related to Bone-Ingrowth
122
122
Naturally Worn
103
103
Migration or Expulsion of Device
79
79
Loose or Intermittent Connection
74
74
Patient Device Interaction Problem
54
54
Mechanical Problem
51
51
Failure to Advance
43
43
Migration
43
43
Unintended Movement
32
32
Packaging Problem
26
26
Compatibility Problem
26
26
Malposition of Device
24
24
Degraded
24
24
Disassembly
24
24
Noise, Audible
21
21
Patient-Device Incompatibility
20
20
Inadequacy of Device Shape and/or Size
18
18
Osseointegration Problem
18
18
Material Deformation
17
17
Mechanical Jam
16
16
Separation Failure
15
15
Component Missing
15
15
Loss of or Failure to Bond
15
15
Detachment Of Device Component
14
14
Material Fragmentation
12
12
Device Appears to Trigger Rejection
12
12
Use of Device Problem
11
11
Tear, Rip or Hole in Device Packaging
11
11
Delivered as Unsterile Product
11
11
Crack
10
10
Material Integrity Problem
10
10
Connection Problem
10
10
Unsealed Device Packaging
9
9
Material Erosion
9
9
Difficult to Insert
8
8
Device Slipped
8
8
Device Operates Differently Than Expected
8
8
Manufacturing, Packaging or Shipping Problem
7
7
Improper or Incorrect Procedure or Method
7
7
Metal Shedding Debris
7
7
Positioning Failure
7
7
Contamination /Decontamination Problem
6
6
Device-Device Incompatibility
5
5
Device Damaged by Another Device
5
5
Scratched Material
5
5
No Apparent Adverse Event
5
5
Corroded
5
5
Material Separation
5
5
Shipping Damage or Problem
4
4
Failure to Osseointegrate
4
4
Component Incompatible
4
4
Failure To Adhere Or Bond
4
4
Material Disintegration
4
4
Product Quality Problem
4
4
No Device Output
4
4
Positioning Problem
4
4
Device Contamination with Chemical or Other Material
4
4
Device Contaminated During Manufacture or Shipping
4
4
Device Markings/Labelling Problem
3
3
Material Twisted/Bent
3
3
Activation Failure
3
3
Sharp Edges
3
3
Separation Problem
3
3
Difficult or Delayed Separation
3
3
Unclear Information
3
3
Fitting Problem
3
3
Defective Component
3
3
Microbial Contamination of Device
3
3
Device Issue
3
3
Expiration Date Error
3
3
Biocompatibility
2
2
Failure to Align
2
2
Defective Device
2
2
Material Rupture
2
2
Device Damaged Prior to Use
2
2
Off-Label Use
2
2
Disconnection
2
2
Activation Problem
2
2
Device Handling Problem
2
2
Operating System Becomes Nonfunctional
2
2
Contamination of Device Ingredient or Reagent
2
2
Device Packaging Compromised
2
2
Device Operational Issue
2
2
Device Unsafe to Use in Environment
1
1
Incorrect Device Or Component Shipped
1
1
Material Protrusion/Extrusion
1
1
Material Distortion
1
1
Output Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Misassembly by Users
1
1
Physical Resistance/Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
1027
1027
Injury
576
576
Pain
525
525
No Information
379
379
Failure of Implant
347
347
Insufficient Information
305
305
No Code Available
263
263
Inadequate Osseointegration
219
219
Cancer
200
200
Bone Fracture(s)
135
135
No Known Impact Or Consequence To Patient
121
122
Ambulation Difficulties
112
112
Fall
108
108
No Clinical Signs, Symptoms or Conditions
106
106
Joint Dislocation
102
102
Loss of Range of Motion
67
67
Swelling
65
65
Limited Mobility Of The Implanted Joint
63
63
Patient Problem/Medical Problem
62
62
Joint Laxity
59
59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
47
47
Joint Disorder
45
45
No Consequences Or Impact To Patient
44
44
Reaction
38
38
Inflammation
37
37
Unequal Limb Length
35
35
Death
25
25
Scar Tissue
24
24
Post Operative Wound Infection
23
23
Not Applicable
22
22
Bacterial Infection
20
20
Necrosis
19
19
Swelling/ Edema
19
19
Osteolysis
18
18
Metal Related Pathology
16
16
Wound Dehiscence
15
15
Hematoma
14
14
Foreign Body Reaction
13
13
Thrombosis
13
13
Tissue Damage
13
13
Unspecified Tissue Injury
11
11
Fluid Discharge
11
11
Ulcer
10
10
Ossification
10
10
Discomfort
9
9
No Patient Involvement
9
9
Post Traumatic Wound Infection
8
8
Sudden Cardiac Death
8
8
Synovitis
8
8
Muscular Rigidity
8
8
Edema
8
8
Cellulitis
7
7
Skin Discoloration
7
7
Staphylococcus Aureus
7
7
Device Embedded In Tissue or Plaque
7
7
Fibrosis
7
7
Implant Pain
6
6
Muscle/Tendon Damage
6
6
Joint Contracture
6
6
Foreign Body In Patient
6
6
Blood Loss
6
6
Adhesion(s)
6
6
Hemorrhage/Bleeding
6
6
Damage to Ligament(s)
6
6
Host-Tissue Reaction
5
5
Discharge
5
5
Impaired Healing
5
5
Fungal Infection
5
5
Osteopenia/ Osteoporosis
4
4
Hypovolemia
4
4
Viral Infection
4
4
Joint Swelling
4
4
Peroneal Nerve Palsy
4
4
Rash
4
4
Muscle Weakness
4
4
Hypersensitivity/Allergic reaction
4
4
Fever
4
4
Sepsis
3
3
Toxicity
3
3
Hip Fracture
3
3
Rupture
2
2
Perforation
2
2
Scarring
2
2
Abscess
2
2
Anemia
2
2
Erythema
2
2
Weight Changes
2
2
Hyperextension
2
2
Subluxation
2
2
Malunion of Bone
1
1
Unspecified Musculoskeletal problem
1
1
Tissue Breakdown
1
1
Vascular System (Circulation), Impaired
1
1
Purulent Discharge
1
1
Chest Pain
1
1
Cyst(s)
1
1
Aortic Valve Stenosis
1
1
Arthritis
1
1
Pulmonary Embolism
1
1
Granuloma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medacta Usa Inc
II
Jun-12-2017
2
Onkos Surgical, Inc.
II
Jun-29-2017
3
Smith & Nephew, Inc.
II
Mar-19-2018
4
Stanmore Implants Worldwide Ltd.
II
Sep-05-2017
5
Uoc Usa Inc
II
Oct-14-2021
6
Zimmer Biomet, Inc.
II
Dec-07-2018
7
Zimmer Biomet, Inc.
II
Feb-26-2018
8
Zimmer Biomet, Inc.
II
Dec-29-2017
9
Zimmer Biomet, Inc.
II
Nov-08-2017
10
Zimmer Biomet, Inc.
II
Mar-20-2017
11
Zimmer Biomet, Inc.
II
Jan-28-2017
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