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TPLC
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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
HERAEUS MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
OSTEOREMEDIES, LLC
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
415
415
2020
269
269
2021
107
107
2022
99
99
2023
49
49
2024
143
143
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
244
244
Device-Device Incompatibility
193
193
Material Twisted/Bent
110
110
Biocompatibility
107
107
Break
105
105
Loss of Osseointegration
94
94
Scratched Material
75
75
Device Dislodged or Dislocated
52
52
Insufficient Information
46
46
Naturally Worn
35
35
Fitting Problem
30
30
Loose or Intermittent Connection
30
30
Appropriate Term/Code Not Available
26
26
Physical Resistance/Sticking
24
24
Material Deformation
21
21
Fracture
18
18
Migration
18
18
Device Contaminated During Manufacture or Shipping
16
16
Nonstandard Device
14
14
Tear, Rip or Hole in Device Packaging
13
13
Degraded
12
12
Osseointegration Problem
12
12
Corroded
11
11
Packaging Problem
10
10
Mechanical Jam
9
9
Inadequacy of Device Shape and/or Size
9
9
Detachment of Device or Device Component
8
8
Difficult to Remove
7
7
Entrapment of Device
7
7
Material Integrity Problem
7
7
Computer System Security Problem
7
7
Patient Device Interaction Problem
7
7
Connection Problem
6
6
Malposition of Device
6
6
Patient-Device Incompatibility
5
5
Defective Device
4
4
Unstable
4
4
Difficult to Insert
4
4
Compatibility Problem
4
4
Use of Device Problem
3
3
Failure to Osseointegrate
3
3
Mechanical Problem
3
3
Unintended Movement
3
3
Crack
3
3
Material Fragmentation
3
3
Migration or Expulsion of Device
3
3
Loosening of Implant Not Related to Bone-Ingrowth
3
3
Device Damaged Prior to Use
2
2
Material Discolored
2
2
Loss of or Failure to Bond
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
320
320
No Code Available
226
226
Pain
163
163
Insufficient Information
113
113
Metal Related Pathology
113
113
Unspecified Infection
93
93
Not Applicable
60
60
Injury
49
49
Test Result
47
47
Bone Fracture(s)
45
45
Joint Dislocation
42
42
Inadequate Osseointegration
42
42
No Clinical Signs, Symptoms or Conditions
35
35
Osteolysis
32
32
Failure of Implant
31
31
Tissue Damage
21
21
Discomfort
21
21
Foreign Body Reaction
20
20
Loss of Range of Motion
18
18
Limited Mobility Of The Implanted Joint
15
15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Infiltration into Tissue
15
15
Inflammation
13
13
Ambulation Difficulties
12
12
Fall
12
12
Arthralgia
11
11
No Known Impact Or Consequence To Patient
11
11
Leiomyosarcoma
11
11
No Information
8
8
Edema
8
8
Necrosis
6
6
Hematoma
6
6
Hypersensitivity/Allergic reaction
6
6
Hip Fracture
5
5
Swelling/ Edema
5
5
Synovitis
5
5
Toxicity
4
4
Implant Pain
4
4
Joint Laxity
4
4
Cyst(s)
4
4
Swelling
4
4
Thrombosis
4
4
No Patient Involvement
4
4
Blood Loss
4
4
Bacterial Infection
3
3
Solid Tumour
3
3
Ossification
3
3
Distress
3
3
Limb Fracture
2
2
Muscle/Tendon Damage
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
Jul-16-2024
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