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TPLC
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Device
prosthesis, hip, semi-constrained, metal/polymer, cemented
Product Code
JDI
Regulation Number
888.3350
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
2
MICROPORT ORTHOPEDICS INC.
SUBSTANTIALLY EQUIVALENT
2
ONKOS SURGICAL
SUBSTANTIALLY EQUIVALENT
3
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
1
STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
UNITED ORTHOPEDIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ZIMMER INC
SUBSTANTIALLY EQUIVALENT
1
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
7405
7405
2020
4015
4015
2021
3171
3171
2022
1980
1980
2023
1651
1796
2024
238
238
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
6685
6735
Device Dislodged or Dislocated
2877
2877
Insufficient Information
2194
2274
Naturally Worn
1529
1529
Fracture
788
808
Break
729
729
Corroded
538
538
Degraded
527
527
Loss of Osseointegration
450
450
Material Erosion
385
385
Loosening of Implant Not Related to Bone-Ingrowth
363
366
Migration
335
341
Detachment of Device or Device Component
331
335
Appropriate Term/Code Not Available
326
326
Osseointegration Problem
299
299
Unstable
299
299
Noise, Audible
212
212
Loss of or Failure to Bond
199
199
Biocompatibility
189
189
Difficult to Insert
174
174
Loose or Intermittent Connection
137
137
Nonstandard Device
120
120
Packaging Problem
120
120
Malposition of Device
111
111
Use of Device Problem
104
104
Material Deformation
96
96
Material Twisted/Bent
90
90
Device Contaminated During Manufacture or Shipping
88
88
Patient Device Interaction Problem
78
78
Unintended Movement
72
72
Connection Problem
67
67
Positioning Failure
66
66
Tear, Rip or Hole in Device Packaging
64
64
Device Markings/Labelling Problem
58
58
Material Disintegration
53
53
Mechanical Problem
46
48
Difficult to Remove
42
42
Incomplete or Inadequate Connection
42
42
Migration or Expulsion of Device
38
42
Inadequacy of Device Shape and/or Size
37
37
Off-Label Use
35
35
Material Fragmentation
34
34
Crack
34
34
No Apparent Adverse Event
34
34
Fitting Problem
33
33
Mechanical Jam
32
32
Defective Device
31
31
Device-Device Incompatibility
30
30
Physical Resistance/Sticking
27
27
Failure to Osseointegrate
27
27
Positioning Problem
24
24
Patient-Device Incompatibility
20
20
Separation Failure
19
19
Device Appears to Trigger Rejection
18
18
Material Integrity Problem
18
18
Premature Separation
17
17
Defective Component
17
17
Delivered as Unsterile Product
17
17
Device Difficult to Setup or Prepare
16
16
Device Damaged Prior to Use
15
15
Manufacturing, Packaging or Shipping Problem
14
14
Difficult or Delayed Positioning
13
13
Improper or Incorrect Procedure or Method
11
11
Dull, Blunt
11
11
Scratched Material
10
10
Inaccurate Information
9
9
Material Separation
9
9
Component Missing
8
8
Flaked
8
8
Difficult or Delayed Separation
8
8
Illegible Information
7
7
Separation Problem
7
7
Material Discolored
7
7
Device Slipped
7
7
Failure to Advance
6
6
Peeled/Delaminated
6
6
Misassembled
6
6
Contamination /Decontamination Problem
6
6
Activation, Positioning or Separation Problem
6
6
Material Frayed
5
5
Expiration Date Error
5
5
Device Contamination with Chemical or Other Material
4
4
Difficult to Open or Remove Packaging Material
4
4
Compatibility Problem
3
3
Component Misassembled
3
3
Missing Information
3
3
Deformation Due to Compressive Stress
3
3
Problem with Sterilization
3
3
Shipping Damage or Problem
3
3
Misconnection
3
3
No Device Output
3
3
Contamination
3
3
Leak/Splash
2
2
Product Quality Problem
2
2
Unsealed Device Packaging
2
2
Disconnection
2
2
Entrapment of Device
2
2
Biofilm coating in Device
2
2
Collapse
2
2
Component Incompatible
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
5171
5171
Pain
4426
4426
Joint Dislocation
2577
2577
Unspecified Infection
2314
2323
Injury
1862
1862
Foreign Body Reaction
1503
1503
Test Result
1289
1289
No Clinical Signs, Symptoms or Conditions
1128
1128
Failure of Implant
1043
1138
Insufficient Information
927
927
No Information
925
925
Inflammation
843
843
Bone Fracture(s)
801
815
Osteolysis
799
799
Tissue Damage
765
765
Inadequate Osseointegration
688
688
Metal Related Pathology
643
643
Ambulation Difficulties
582
582
Reaction
562
562
Hypersensitivity/Allergic reaction
553
553
No Consequences Or Impact To Patient
526
526
Discomfort
515
515
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
483
483
Joint Laxity
451
451
No Known Impact Or Consequence To Patient
395
395
Limited Mobility Of The Implanted Joint
392
392
Loss of Range of Motion
345
345
Fall
288
288
Necrosis
241
241
Edema
225
225
Swelling/ Edema
203
203
No Patient Involvement
189
189
Adhesion(s)
177
177
Unspecified Tissue Injury
176
176
Ossification
153
153
Scar Tissue
140
159
Hematoma
137
137
Synovitis
123
123
Swelling
121
121
Hemorrhage/Bleeding
104
104
Joint Disorder
104
104
Weakness
97
97
Hip Fracture
93
93
Fatigue
93
93
Host-Tissue Reaction
93
93
Osteopenia/ Osteoporosis
92
92
Physical Asymmetry
90
90
Thrombosis
88
88
Pulmonary Embolism
87
87
Distress
85
85
Local Reaction
84
84
Cyst(s)
84
84
Not Applicable
71
71
Wound Dehiscence
70
70
Nerve Damage
67
67
Fever
65
65
Fluid Discharge
64
64
Bacterial Infection
57
57
Muscular Rigidity
54
54
Anxiety
54
54
Death
52
52
Deformity/ Disfigurement
51
51
Muscle/Tendon Damage
51
51
Impaired Healing
50
58
Blood Loss
46
46
Hypoesthesia
44
44
Unequal Limb Length
40
40
Sepsis
39
39
Erythema
38
38
Limb Fracture
36
36
Post Operative Wound Infection
35
35
Thrombosis/Thrombus
34
34
Pocket Erosion
34
34
Abscess
33
33
Erosion
32
32
Depression
30
30
Rash
29
29
Implant Pain
28
28
Foreign Body In Patient
26
26
Myocardial Infarction
26
26
Renal Failure
24
24
Cardiac Arrest
24
24
Anemia
24
24
Toxicity
24
24
Numbness
23
23
Reaction to Medicinal Component of Device
22
22
Headache
22
22
Memory Loss/Impairment
21
21
Seroma
21
21
Tinnitus
21
21
Stroke/CVA
20
20
Low Blood Pressure/ Hypotension
19
19
Unspecified Musculoskeletal problem
18
18
Fibrosis
18
18
Subluxation
17
17
Arthralgia
17
17
Pneumonia
17
17
Arrhythmia
16
16
Infarction, Cerebral
15
15
Calcium Deposits/Calcification
14
14
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Dec-17-2020
2
Biomet, Inc.
II
Oct-09-2020
3
Biomet, Inc.
II
May-28-2020
4
Corin Ltd
II
Aug-31-2022
5
Corin Ltd
II
Aug-09-2022
6
DePuy Orthopaedics, Inc.
II
Jun-10-2021
7
Exactech, Inc.
II
Sep-09-2022
8
Howmedica Osteonics Corp.
II
Jan-15-2020
9
MicroPort Orthopedics Inc.
II
Jun-02-2022
10
Zimmer Biomet, Inc.
II
Nov-02-2020
11
Zimmer Biomet, Inc.
II
Aug-09-2019
12
Zimmer, Inc.
II
Sep-07-2023
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