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TPLC
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show TPLC since
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2024
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Device
prosthesis, hip, hemi-, femoral, metal
Product Code
KWL
Regulation Number
888.3360
Device Class
2
Premarket Reviews
Manufacturer
Decision
CORIN U.S.A.
SUBSTANTIALLY EQUIVALENT
1
HERAEUS MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
MANDELL HORWITZ CONSULTANTS LLC
SUBSTANTIALLY EQUIVALENT
1
OSTEOREMEDIES LLC
SUBSTANTIALLY EQUIVALENT
1
OSTEOREMEDIES, LLC
SUBSTANTIALLY EQUIVALENT
3
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
1
TECRES SPA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
107
107
2015
222
222
2016
210
210
2017
347
347
2018
294
294
2019
415
415
2020
269
269
2021
107
107
2022
99
99
2023
49
49
2024
125
125
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
520
520
Adverse Event Without Identified Device or Use Problem
363
363
Loss of Osseointegration
240
240
Device-Device Incompatibility
204
204
Appropriate Term/Code Not Available
187
187
Device Dislodged or Dislocated
146
146
Break
130
130
Material Twisted/Bent
113
113
Biocompatibility
103
103
Scratched Material
77
77
Corroded
66
66
Fracture
58
58
Fitting Problem
57
57
Migration or Expulsion of Device
57
57
Naturally Worn
50
50
Loose or Intermittent Connection
48
48
Degraded
36
36
Osseointegration Problem
30
30
Material Deformation
29
29
Nonstandard Device
26
26
Physical Resistance/Sticking
25
25
Inadequacy of Device Shape and/or Size
24
24
Migration
23
23
Detachment Of Device Component
17
17
Malposition of Device
17
17
Device Contaminated During Manufacture or Shipping
17
17
Loss of or Failure to Bond
16
16
Tear, Rip or Hole in Device Packaging
14
14
Packaging Problem
14
14
Device Operates Differently Than Expected
14
14
Material Integrity Problem
12
12
Metal Shedding Debris
11
11
Difficult to Remove
11
11
Noise, Audible
10
10
Mechanical Problem
10
10
Mechanical Jam
10
10
Device Slipped
9
9
Detachment of Device or Device Component
8
8
Entrapment of Device
8
8
Patient Device Interaction Problem
8
8
Positioning Problem
8
8
Connection Problem
8
8
Unstable
8
8
Patient-Device Incompatibility
7
7
Defective Device
7
7
Difficult to Insert
7
7
Computer System Security Problem
7
7
Failure to Osseointegrate
7
7
Compatibility Problem
6
6
Crack
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
517
517
No Code Available
405
405
No Consequences Or Impact To Patient
400
400
Injury
249
249
Unspecified Infection
238
238
Bone Fracture(s)
185
185
No Information
178
178
Not Applicable
116
116
Joint Dislocation
115
115
Metal Related Pathology
113
113
Insufficient Information
111
111
Inadequate Osseointegration
101
101
Discomfort
89
89
Test Result
79
79
Inflammation
75
75
Foreign Body Reaction
68
68
Osteolysis
64
64
Tissue Damage
62
62
Fall
57
57
No Known Impact Or Consequence To Patient
56
56
Failure of Implant
54
54
Host-Tissue Reaction
47
47
Ambulation Difficulties
45
45
Limited Mobility Of The Implanted Joint
43
43
Reaction
42
42
Loss of Range of Motion
40
40
No Clinical Signs, Symptoms or Conditions
35
35
Necrosis
21
21
Swelling
20
20
Distress
19
19
Hypersensitivity/Allergic reaction
17
17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Infiltration into Tissue
15
15
Weakness
15
15
Edema
15
15
Blood Loss
14
14
Toxicity
13
13
Synovitis
12
12
Leiomyosarcoma
11
11
Arthralgia
9
9
Thrombosis
8
8
Hip Fracture
8
8
Hematoma
8
8
Fatigue
7
7
Anxiety
7
7
Swelling/ Edema
7
7
Cyst(s)
6
6
Arthritis
6
6
Ossification
5
5
Fluid Discharge
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Oct-11-2018
2
DePuy Orthopaedics, Inc.
II
Feb-12-2018
3
Howmedica Osteonics Corp.
II
Jul-16-2024
4
Smith & Nephew, Inc.
II
Jan-05-2016
5
Stryker Howmedica Osteonics Corp.
III
Sep-14-2009
6
Stryker Howmedica Osteonics Corp.
II
Jul-22-2009
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