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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
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
LINK BIO CORP.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
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
2018
614
614
2019
759
759
2020
749
749
2021
767
767
2022
897
897
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1343
1343
Insufficient Information
605
605
Fracture
375
375
Loss of Osseointegration
233
233
Device Dislodged or Dislocated
175
175
Unstable
160
160
Detachment of Device or Device Component
142
142
Appropriate Term/Code Not Available
140
140
Loosening of Implant Not Related to Bone-Ingrowth
134
134
Break
126
126
Naturally Worn
113
113
Loose or Intermittent Connection
61
61
Patient Device Interaction Problem
54
54
Mechanical Problem
50
50
Migration
48
48
Failure to Advance
45
45
Degraded
42
42
Migration or Expulsion of Device
37
37
Unintended Movement
27
27
Compatibility Problem
26
26
Osseointegration Problem
23
23
Patient-Device Incompatibility
20
20
Device Appears to Trigger Rejection
19
19
Inadequacy of Device Shape and/or Size
17
17
Packaging Problem
17
17
Malposition of Device
17
17
Noise, Audible
15
15
Material Deformation
15
15
Separation Failure
15
15
Material Fragmentation
12
12
Mechanical Jam
12
12
Component Missing
12
12
Loss of or Failure to Bond
12
12
Material Erosion
12
12
Use of Device Problem
11
11
Crack
10
10
Delivered as Unsterile Product
10
10
Connection Problem
9
9
Unsealed Device Packaging
9
9
Material Integrity Problem
9
9
Detachment Of Device Component
9
9
Improper or Incorrect Procedure or Method
9
9
Tear, Rip or Hole in Device Packaging
8
8
Manufacturing, Packaging or Shipping Problem
8
8
Disassembly
8
8
Shipping Damage or Problem
7
7
No Apparent Adverse Event
7
7
Contamination /Decontamination Problem
7
7
Device Slipped
6
6
Difficult to Insert
5
5
Device Contaminated During Manufacture or Shipping
5
5
Corroded
5
5
Component Incompatible
5
5
Positioning Failure
4
4
Material Disintegration
4
4
Device Damaged by Another Device
4
4
Material Separation
4
4
Failure to Osseointegrate
4
4
Device-Device Incompatibility
4
4
Positioning Problem
4
4
Scratched Material
3
3
Activation Failure
3
3
Sharp Edges
3
3
No Device Output
3
3
Microbial Contamination of Device
3
3
Separation Problem
3
3
Difficult or Delayed Separation
3
3
Fitting Problem
3
3
Defective Component
3
3
Expiration Date Error
3
3
Material Twisted/Bent
3
3
Unclear Information
3
3
Operating System Becomes Nonfunctional
2
2
Device Handling Problem
2
2
Off-Label Use
2
2
Device Contamination with Chemical or Other Material
2
2
Product Quality Problem
2
2
Activation Problem
2
2
Failure to Align
2
2
Defective Device
2
2
Device Difficult to Setup or Prepare
2
2
Nonstandard Device
2
2
Biocompatibility
2
2
Material Rupture
2
2
Device Damaged Prior to Use
2
2
Disconnection
2
2
Electrical /Electronic Property Problem
1
1
Material Frayed
1
1
Difficult or Delayed Activation
1
1
Ambient Noise Problem
1
1
Material Distortion
1
1
Device Unsafe to Use in Environment
1
1
Unintended Compatibility
1
1
Metal Shedding Debris
1
1
Labelling, Instructions for Use or Training Problem
1
1
Incorrect Measurement
1
1
Collapse
1
1
Difficult to Open or Remove Packaging Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
1134
1134
Injury
538
538
Pain
476
476
Insufficient Information
416
416
Failure of Implant
368
368
No Information
240
240
Inadequate Osseointegration
221
221
No Code Available
220
220
Cancer
147
147
No Clinical Signs, Symptoms or Conditions
130
130
Ambulation Difficulties
128
128
Bone Fracture(s)
122
122
Fall
117
117
Joint Dislocation
92
92
No Known Impact Or Consequence To Patient
92
93
Joint Laxity
73
73
Loss of Range of Motion
68
68
Patient Problem/Medical Problem
59
59
Swelling
56
56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
48
48
Limited Mobility Of The Implanted Joint
42
42
Joint Disorder
40
40
Unequal Limb Length
40
40
Inflammation
39
39
Scar Tissue
34
34
Swelling/ Edema
28
28
No Consequences Or Impact To Patient
27
27
Reaction
25
25
Death
24
24
Metal Related Pathology
23
23
Not Applicable
22
22
Hematoma
19
19
Post Operative Wound Infection
19
19
Osteolysis
18
18
Wound Dehiscence
16
16
Bacterial Infection
15
15
Foreign Body Reaction
14
14
Unspecified Tissue Injury
14
14
Muscular Rigidity
12
12
Tissue Damage
11
11
Fluid Discharge
11
11
Thrombosis
10
10
Ulcer
10
10
Synovitis
10
10
Necrosis
9
9
Edema
8
8
Post Traumatic Wound Infection
8
8
Ossification
8
8
Adhesion(s)
8
8
Discomfort
8
8
No Patient Involvement
8
8
Sudden Cardiac Death
8
8
Hyperextension
7
7
Skin Discoloration
7
7
Staphylococcus Aureus
7
7
Implant Pain
7
7
Joint Contracture
6
6
Hemorrhage/Bleeding
6
6
Damage to Ligament(s)
6
6
Muscle/Tendon Damage
6
6
Blood Loss
6
6
Osteopenia/ Osteoporosis
5
5
Foreign Body In Patient
5
5
Discharge
4
4
Hypovolemia
4
4
Fever
4
4
Rash
4
4
Host-Tissue Reaction
4
4
Impaired Healing
4
4
Rupture
3
3
Sepsis
3
3
Hip Fracture
3
3
Hypersensitivity/Allergic reaction
3
3
Joint Swelling
3
3
Abdominal Pain
2
2
Stroke/CVA
2
2
Subluxation
2
2
Weight Changes
2
2
Toxicity
2
2
Fungal Infection
2
2
Erythema
2
2
Abscess
2
2
Anemia
2
2
Scarring
2
2
Device Embedded In Tissue or Plaque
2
2
Unspecified Musculoskeletal problem
1
1
Tissue Breakdown
1
1
Nerve Damage
1
1
Chest Pain
1
1
Fistula
1
1
Granuloma
1
1
Weakness
1
1
Distress
1
1
Aortic Valve Stenosis
1
1
Infiltration into Tissue
1
1
Neuropathy
1
1
Perforation
1
1
Malunion of Bone
1
1
Vascular System (Circulation), Impaired
1
1
Cellulitis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Smith & Nephew, Inc.
II
Mar-19-2018
2
Uoc Usa Inc
II
Oct-14-2021
3
Zimmer Biomet, Inc.
II
Dec-07-2018
4
Zimmer Biomet, Inc.
II
Feb-26-2018
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