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TPLC
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Device
prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Product Code
KWZ
Regulation Number
888.3310
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
ENCORE MEDICAL, L.P.
SUBSTANTIALLY EQUIVALENT
2
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
4
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
278
278
2015
634
634
2016
1181
1181
2017
478
478
2018
282
282
2019
533
533
2020
288
288
2021
216
216
2022
158
158
2023
165
165
2024
109
109
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
1502
1502
Insufficient Information
1119
1119
Adverse Event Without Identified Device or Use Problem
399
399
Fracture
243
243
Naturally Worn
208
208
Appropriate Term/Code Not Available
185
185
Failure To Adhere Or Bond
149
149
Migration or Expulsion of Device
114
114
Break
101
101
Corroded
99
99
Unstable
82
82
Device Contaminated During Manufacture or Shipping
68
68
Detachment of Device or Device Component
52
52
Difficult to Insert
46
46
Disassembly
45
45
Malposition of Device
43
43
Noise, Audible
30
30
Loose or Intermittent Connection
28
28
Mechanical Problem
24
24
Device Slipped
21
21
Device Operates Differently Than Expected
21
21
Material Erosion
20
20
Material Deformation
20
20
Detachment Of Device Component
19
19
Material Separation
19
19
Scratched Material
19
19
Loss of Osseointegration
18
18
Fitting Problem
18
18
Nonstandard Device
15
15
Packaging Problem
15
15
Off-Label Use
13
13
Loss of or Failure to Bond
13
13
Positioning Failure
12
12
Device-Device Incompatibility
11
11
Material Integrity Problem
11
11
Positioning Problem
11
11
Loosening of Implant Not Related to Bone-Ingrowth
11
11
Improper or Incorrect Procedure or Method
10
10
Tear, Rip or Hole in Device Packaging
10
10
Difficult to Remove
10
10
Separation Failure
10
10
Metal Shedding Debris
9
9
Unintended Movement
9
9
Use of Device Problem
9
9
Migration
9
9
Compatibility Problem
8
8
Biocompatibility
7
7
Crack
7
7
Failure to Osseointegrate
6
6
Inadequacy of Device Shape and/or Size
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
1023
1023
Joint Dislocation
918
918
No Information
878
878
Pain
577
577
Unspecified Infection
428
428
Injury
265
265
Osteolysis
122
122
Bone Fracture(s)
104
104
No Known Impact Or Consequence To Patient
100
100
Foreign Body Reaction
100
100
Fall
94
94
Insufficient Information
90
90
No Clinical Signs, Symptoms or Conditions
87
87
No Consequences Or Impact To Patient
85
85
Reaction
77
77
Ambulation Difficulties
67
67
Not Applicable
63
63
Tissue Damage
60
60
Failure of Implant
59
59
No Patient Involvement
56
56
Loss of Range of Motion
54
54
Joint Laxity
52
52
Limited Mobility Of The Implanted Joint
52
52
Discomfort
45
45
Swelling
43
43
Test Result
42
42
Inflammation
40
40
Ossification
36
36
Hematoma
36
36
Hip Fracture
30
30
Toxicity
29
30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
28
28
Hypersensitivity/Allergic reaction
24
24
Death
22
22
Thrombosis
17
17
Erosion
16
16
Scar Tissue
15
15
Necrosis
14
14
Pulmonary Embolism
14
14
Edema
14
14
Inadequate Osseointegration
13
13
Impaired Healing
13
13
Osteopenia/ Osteoporosis
13
13
Host-Tissue Reaction
13
13
Metal Related Pathology
12
12
Adhesion(s)
12
12
Joint Disorder
10
10
Fatigue
10
10
Swelling/ Edema
9
9
Unspecified Tissue Injury
9
9
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Sep-20-2012
2
Encore Medical, Lp
II
Apr-10-2019
3
Exactech, Inc.
II
Jan-18-2024
4
Exactech, Inc.
II
Sep-09-2022
5
Smith & Nephew Inc
II
Oct-18-2010
6
Smith & Nephew, Inc.
II
Jun-09-2015
7
Zimmer, Inc.
II
Nov-20-2012
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