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Device
prosthesis, hip, hemi-, femoral, metal
Regulation Description
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product Code
KWL
Regulation Number
888.3360
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOCOMPOSITES LTD.
SUBSTANTIALLY EQUIVALENT
1
HERAEUS MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
OSTEOREMEDIES, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
269
269
2021
107
107
2022
99
99
2023
49
49
2024
144
144
2025
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
172
172
Biocompatibility
102
102
Loss of Osseointegration
76
76
Device-Device Incompatibility
59
59
Break
56
56
Material Twisted/Bent
48
48
Device Dislodged or Dislocated
39
39
Insufficient Information
34
34
Loose or Intermittent Connection
28
28
Appropriate Term/Code Not Available
21
21
Device Contaminated During Manufacture or Shipping
16
16
Scratched Material
14
14
Tear, Rip or Hole in Device Packaging
13
13
Material Deformation
13
13
Fracture
12
12
Naturally Worn
11
11
Packaging Problem
10
10
Migration
9
9
Detachment of Device or Device Component
9
9
Corroded
8
8
Osseointegration Problem
7
7
Computer System Security Problem
7
7
Physical Resistance/Sticking
7
7
Material Integrity Problem
7
7
Degraded
5
5
Patient Device Interaction Problem
5
5
Defective Device
4
4
Malposition of Device
4
4
Mechanical Jam
4
4
Compatibility Problem
4
4
Unstable
4
4
Material Fragmentation
3
3
Failure to Osseointegrate
3
3
Inadequacy of Device Shape and/or Size
3
3
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Difficult to Insert
2
2
Unsealed Device Packaging
2
2
Unintended Movement
2
2
Patient-Device Incompatibility
2
2
No Apparent Adverse Event
2
2
Device Damaged Prior to Use
2
2
Crack
2
2
Entrapment of Device
2
2
Difficult to Remove
1
1
Material Discolored
1
1
Use of Device Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Difficult to Advance
1
1
Device Markings/Labelling Problem
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
119
119
Metal Related Pathology
117
117
Insufficient Information
113
113
No Consequences Or Impact To Patient
107
107
Pain
94
94
Unspecified Infection
67
67
Bone Fracture(s)
36
36
Joint Dislocation
35
35
No Clinical Signs, Symptoms or Conditions
35
35
Failure of Implant
29
29
Inadequate Osseointegration
24
24
Osteolysis
20
20
Injury
20
20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Infiltration into Tissue
15
15
Loss of Range of Motion
12
12
Not Applicable
12
12
Arthralgia
11
11
Ambulation Difficulties
11
11
Leiomyosarcoma
11
11
Fall
9
9
No Known Impact Or Consequence To Patient
7
7
Limited Mobility Of The Implanted Joint
6
6
Foreign Body Reaction
6
6
Swelling/ Edema
5
5
Implant Pain
5
5
Inflammation
5
5
Test Result
5
5
Synovitis
4
4
Edema
4
4
Necrosis
4
4
No Patient Involvement
4
4
Hip Fracture
4
4
Joint Laxity
4
4
Hematoma
3
3
Ossification
3
3
Bacterial Infection
3
3
Discomfort
3
3
Solid Tumour
3
3
Hypersensitivity/Allergic reaction
3
3
Muscle Weakness
2
2
Cyst(s)
2
2
Foreign Body In Patient
2
2
Unspecified Eye / Vision Problem
2
2
Wound Dehiscence
2
2
Toxicity
2
2
Muscle/Tendon Damage
2
2
Headache
1
1
Hemorrhage/Bleeding
1
1
Tinnitus
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
Jul-16-2024
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