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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
2
LINK BIO CORP.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
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
2018
614
614
2019
759
759
2020
749
749
2021
767
767
2022
893
893
2023
495
495
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1590
1590
Insufficient Information
635
635
Fracture
430
430
Loss of Osseointegration
257
257
Device Dislodged or Dislocated
193
193
Unstable
185
185
Detachment of Device or Device Component
168
168
Loosening of Implant Not Related to Bone-Ingrowth
164
164
Appropriate Term/Code Not Available
142
142
Naturally Worn
141
141
Break
127
127
Loose or Intermittent Connection
61
61
Mechanical Problem
54
54
Patient Device Interaction Problem
54
54
Migration
49
49
Failure to Advance
49
49
Degraded
47
47
Migration or Expulsion of Device
37
37
Unintended Movement
37
37
Osseointegration Problem
30
30
Device Appears to Trigger Rejection
27
27
Compatibility Problem
26
26
Patient-Device Incompatibility
20
20
Noise, Audible
19
19
Packaging Problem
18
18
Malposition of Device
18
18
Inadequacy of Device Shape and/or Size
18
18
Separation Failure
16
16
Material Deformation
16
16
Use of Device Problem
15
15
Mechanical Jam
14
14
Improper or Incorrect Procedure or Method
13
13
Component Missing
13
13
Material Erosion
13
13
Loss of or Failure to Bond
12
12
Material Fragmentation
12
12
Delivered as Unsterile Product
12
12
Crack
11
11
Tear, Rip or Hole in Device Packaging
10
10
Shipping Damage or Problem
10
10
Detachment Of Device Component
9
9
Unsealed Device Packaging
9
9
Manufacturing, Packaging or Shipping Problem
9
9
No Apparent Adverse Event
9
9
Material Integrity Problem
9
9
Connection Problem
9
9
Activation Failure
8
8
Positioning Failure
8
8
Disassembly
8
8
Off-Label Use
7
7
Contamination /Decontamination Problem
7
7
Device Slipped
6
6
Corroded
6
6
Difficult to Insert
6
6
Component Incompatible
5
5
Device Contaminated During Manufacture or Shipping
5
5
Device Damaged by Another Device
5
5
Device-Device Incompatibility
5
5
Positioning Problem
4
4
Unclear Information
4
4
Material Disintegration
4
4
Material Separation
4
4
Failure to Osseointegrate
4
4
Expiration Date Error
4
4
Fitting Problem
3
3
Defective Component
3
3
Microbial Contamination of Device
3
3
Material Rupture
3
3
No Device Output
3
3
Separation Problem
3
3
Difficult or Delayed Separation
3
3
Sharp Edges
3
3
Scratched Material
3
3
Material Twisted/Bent
3
3
Device Contamination with Chemical or Other Material
2
2
Operating System Becomes Nonfunctional
2
2
Device Handling Problem
2
2
Misassembly by Users
2
2
Physical Resistance/Sticking
2
2
Activation Problem
2
2
Nonstandard Device
2
2
Device Difficult to Setup or Prepare
2
2
Disconnection
2
2
Difficult or Delayed Positioning
2
2
Product Quality Problem
2
2
Device Damaged Prior to Use
2
2
Defective Device
2
2
Biocompatibility
2
2
Failure to Align
2
2
Difficult or Delayed Activation
1
1
Dent in Material
1
1
Component or Accessory Incompatibility
1
1
Ambient Noise Problem
1
1
Metal Shedding Debris
1
1
Difficult to Remove
1
1
Unexpected Therapeutic Results
1
1
Material Discolored
1
1
Electrical /Electronic Property Problem
1
1
Contamination
1
1
Failure To Adhere Or Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
1299
1299
Insufficient Information
542
542
Injury
538
538
Pain
521
521
Failure of Implant
416
416
Inadequate Osseointegration
247
247
No Information
241
241
No Code Available
220
220
No Clinical Signs, Symptoms or Conditions
164
164
Cancer
150
150
Ambulation Difficulties
140
140
Bone Fracture(s)
138
138
Fall
134
134
Joint Laxity
108
108
Joint Dislocation
106
106
No Known Impact Or Consequence To Patient
92
93
Loss of Range of Motion
83
83
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
62
62
Patient Problem/Medical Problem
59
59
Swelling
56
56
Unequal Limb Length
50
50
Scar Tissue
49
49
Limited Mobility Of The Implanted Joint
42
42
Joint Disorder
40
40
Inflammation
39
39
Swelling/ Edema
34
34
No Consequences Or Impact To Patient
27
27
Reaction
25
25
Death
24
24
Hematoma
22
22
Metal Related Pathology
22
22
Not Applicable
22
22
Osteolysis
19
19
Post Operative Wound Infection
19
19
Wound Dehiscence
18
18
Bacterial Infection
17
17
Fluid Discharge
17
17
Unspecified Tissue Injury
16
16
Foreign Body Reaction
15
15
Synovitis
13
13
Muscular Rigidity
13
13
Muscle/Tendon Damage
13
13
Tissue Damage
11
11
Ulcer
10
10
Discomfort
10
10
Thrombosis
10
10
Adhesion(s)
10
10
Hyperextension
10
10
Implant Pain
9
9
Necrosis
9
9
Ossification
8
8
Edema
8
8
Damage to Ligament(s)
8
8
No Patient Involvement
8
8
Post Traumatic Wound Infection
8
8
Sudden Cardiac Death
8
8
Joint Contracture
7
7
Staphylococcus Aureus
7
7
Skin Discoloration
7
7
Hemorrhage/Bleeding
7
7
Hypersensitivity/Allergic reaction
6
6
Blood Loss
6
6
Osteopenia/ Osteoporosis
5
5
Foreign Body In Patient
5
5
Impaired Healing
4
4
Fever
4
4
Host-Tissue Reaction
4
4
Rash
4
4
Hip Fracture
4
4
Sepsis
4
4
Discharge
4
4
Hypovolemia
4
4
Rupture
3
3
Joint Swelling
3
3
Ischemia
3
3
Limb Fracture
3
3
Device Embedded In Tissue or Plaque
2
2
Fibrosis
2
2
Subluxation
2
2
Unspecified Musculoskeletal problem
2
2
Fungal Infection
2
2
Weight Changes
2
2
Anemia
2
2
Erythema
2
2
Stroke/CVA
2
2
Abdominal Pain
2
2
Abscess
2
2
Toxicity
2
2
Scarring
2
2
Skin Erosion
1
1
Local Reaction
1
1
Renal Failure
1
1
Myocardial Infarction
1
1
Perforation
1
1
Arthralgia
1
1
Non-union Bone Fracture
1
1
Weakness
1
1
Distress
1
1
Calcium Deposits/Calcification
1
1
Cellulitis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Mar-17-2023
2
Linkbio Corp.
II
May-04-2023
3
Smith & Nephew, Inc.
II
Mar-19-2018
4
Uoc Usa Inc
II
Oct-14-2021
5
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Jun-30-2023
6
Zimmer Biomet, Inc.
II
Dec-07-2018
7
Zimmer Biomet, Inc.
II
Feb-26-2018
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