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Device
prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Regulation Description
Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Product Code
KRO
Regulation Number
888.3510
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
2
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
2
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
MICROPORT ORTHOPEDICS INC.
SUBSTANTIALLY EQUIVALENT
2
ONKOS SURGICAL
SUBSTANTIALLY EQUIVALENT
1
STRYKER
SUBSTANTIALLY EQUIVALENT
1
WALDEMAR LINK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
2
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
749
749
2021
767
767
2022
893
893
2023
747
747
2024
858
858
2025
259
364
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1967
2072
Fracture
446
481
Insufficient Information
430
430
Loosening of Implant Not Related to Bone-Ingrowth
233
331
Loss of Osseointegration
216
216
Device Dislodged or Dislocated
169
204
Detachment of Device or Device Component
169
169
Unstable
149
149
Naturally Worn
122
122
Appropriate Term/Code Not Available
97
97
Device Appears to Trigger Rejection
91
91
Patient Device Interaction Problem
67
67
Migration
55
55
Break
54
54
Loose or Intermittent Connection
47
47
Patient-Device Incompatibility
45
45
Failure to Advance
43
43
Osseointegration Problem
40
40
Degraded
40
40
Unintended Movement
37
37
Mechanical Problem
34
34
Separation Failure
21
21
Inadequacy of Device Shape and/or Size
17
17
Use of Device Problem
17
17
Improper or Incorrect Procedure or Method
16
16
Malposition of Device
13
13
Material Erosion
13
55
Loss of or Failure to Bond
13
13
Compatibility Problem
12
12
Tear, Rip or Hole in Device Packaging
12
12
Packaging Problem
12
12
Noise, Audible
11
11
No Apparent Adverse Event
11
11
Shipping Damage or Problem
10
10
Material Fragmentation
10
10
Corroded
10
10
Connection Problem
9
9
Migration or Expulsion of Device
9
9
Activation Failure
9
9
Biocompatibility
8
8
Unsealed Device Packaging
8
8
Delivered as Unsterile Product
8
8
Failure to Osseointegrate
8
8
Mechanical Jam
8
8
Off-Label Use
7
7
Positioning Failure
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Component Missing
7
7
Expiration Date Error
6
6
Material Separation
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
1195
1300
Insufficient Information
782
852
Failure of Implant
465
465
Pain
440
440
Joint Laxity
226
324
No Clinical Signs, Symptoms or Conditions
215
215
Inadequate Osseointegration
210
210
Ambulation Difficulties
172
172
Injury
152
152
Joint Dislocation
152
152
Fall
130
130
Bone Fracture(s)
125
230
No Code Available
96
96
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
88
88
Loss of Range of Motion
81
158
Cancer
61
61
No Information
59
59
Scar Tissue
56
56
Implant Pain
52
52
Unequal Limb Length
51
51
Swelling/ Edema
49
49
Metal Related Pathology
41
41
Inflammation
39
39
No Known Impact Or Consequence To Patient
36
36
Unspecified Tissue Injury
27
27
Adhesion(s)
23
23
Fluid Discharge
23
23
Hematoma
22
64
Hypersensitivity/Allergic reaction
21
21
Wound Dehiscence
21
21
Muscle/Tendon Damage
19
19
Hyperextension
17
17
Osteolysis
17
101
Foreign Body Reaction
15
15
Muscular Rigidity
14
14
Bacterial Infection
14
14
Osteopenia/ Osteoporosis
13
13
Joint Contracture
12
12
Synovitis
12
12
Joint Disorder
12
12
Necrosis
10
10
Post Traumatic Wound Infection
10
10
Post Operative Wound Infection
10
10
Swelling
10
10
Reaction
10
10
Patient Problem/Medical Problem
10
10
Ulcer
10
10
Damage to Ligament(s)
9
9
Ossification
9
9
Discomfort
9
9
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Mar-17-2023
2
Linkbio Corp.
II
May-04-2023
3
Onkos Surgical, Inc.
II
May-29-2025
4
Onkos Surgical, Inc.
II
May-28-2025
5
United Orthopedic Corporation
II
Feb-29-2024
6
Uoc Usa Inc
II
Oct-14-2021
7
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Jun-30-2023
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