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TPLC
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Device
prosthesis, hip, semi-constrained, metal/polymer, uncemented
Regulation Description
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product Code
LWJ
Regulation Number
888.3360
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
189
189
2021
155
155
2022
91
91
2023
72
72
2024
54
54
2025
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
128
128
Break
109
109
Insufficient Information
63
63
Device Dislodged or Dislocated
61
61
Fracture
53
53
Loss of Osseointegration
23
23
Osseointegration Problem
23
23
Corroded
20
20
Detachment of Device or Device Component
14
14
Mechanical Problem
12
12
Appropriate Term/Code Not Available
12
12
Migration
10
10
Mechanical Jam
10
10
Naturally Worn
8
8
Difficult to Remove
7
7
Degraded
7
7
No Apparent Adverse Event
7
7
Use of Device Problem
6
6
Material Integrity Problem
6
6
Biocompatibility
5
5
Loosening of Implant Not Related to Bone-Ingrowth
5
5
Patient Device Interaction Problem
5
5
Loose or Intermittent Connection
5
5
Compatibility Problem
4
4
Device Appears to Trigger Rejection
4
4
Physical Resistance/Sticking
4
4
Material Fragmentation
3
3
Material Disintegration
3
3
Packaging Problem
3
3
Failure to Osseointegrate
3
3
Noise, Audible
3
3
Tear, Rip or Hole in Device Packaging
3
3
Delivered as Unsterile Product
3
3
Patient-Device Incompatibility
3
3
Inadequacy of Device Shape and/or Size
2
2
Entrapment of Device
2
2
Scratched Material
2
2
Unstable
2
2
Device Fell
2
2
Migration or Expulsion of Device
2
2
Malposition of Device
2
2
Unexpected Therapeutic Results
1
1
Expulsion
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Device-Device Incompatibility
1
1
Connection Problem
1
1
Component or Accessory Incompatibility
1
1
Defective Device
1
1
Separation Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
97
97
Pain
79
79
No Clinical Signs, Symptoms or Conditions
69
69
No Information
62
62
Failure of Implant
58
58
Bone Fracture(s)
56
56
Unspecified Infection
39
39
Inadequate Osseointegration
28
28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
27
27
Metal Related Pathology
22
22
No Code Available
20
20
Joint Dislocation
17
17
Foreign Body Reaction
13
13
Loss of Range of Motion
13
13
Osteolysis
13
13
Joint Laxity
12
12
Limb Fracture
11
11
Fall
11
11
No Known Impact Or Consequence To Patient
9
9
Hypersensitivity/Allergic reaction
9
9
Hip Fracture
9
9
Unequal Limb Length
7
7
Joint Disorder
7
7
Injury
7
7
Patient Problem/Medical Problem
6
6
Discomfort
6
6
Bacterial Infection
5
5
Ambulation Difficulties
5
5
Swelling/ Edema
4
4
Unspecified Tissue Injury
4
4
Inflammation
4
4
Necrosis
4
4
Wound Dehiscence
4
4
Foreign Body In Patient
3
3
Synovitis
3
3
Swelling
3
3
Fatigue
3
3
Implant Pain
2
2
Test Result
2
2
Subluxation
2
2
Device Embedded In Tissue or Plaque
2
2
Fibrosis
2
2
Hemorrhage/Bleeding
2
2
Hematoma
2
2
Thrombosis/Thrombus
2
2
Fever
2
2
Edema
2
2
Dyspnea
2
2
Ossification
2
2
Shaking/Tremors
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
Jan-31-2024
2
MicroPort Orthopedics Inc.
I
Sep-18-2020
3
MicroPort Orthopedics Inc.
II
Sep-09-2020
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