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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., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
2
MAXX ORTHOPEDICS, INC
SUBSTANTIALLY EQUIVALENT
1
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
2018
6744
6744
2019
7417
7417
2020
4034
4034
2021
3208
3208
2022
2062
2062
2023
517
517
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7179
7179
Insufficient Information
4693
4693
Device Dislodged or Dislocated
3594
3594
Naturally Worn
1926
1926
Fracture
972
972
Break
868
868
Appropriate Term/Code Not Available
865
865
Corroded
700
700
Loss of Osseointegration
558
558
Degraded
531
531
Material Erosion
419
419
Migration
366
366
Unstable
353
353
Osseointegration Problem
338
338
Noise, Audible
324
324
Loosening of Implant Not Related to Bone-Ingrowth
320
320
Detachment of Device or Device Component
289
289
Loose or Intermittent Connection
289
289
Biocompatibility
270
270
Loss of or Failure to Bond
222
222
Difficult to Insert
212
212
Material Disintegration
185
185
Packaging Problem
174
174
Migration or Expulsion of Device
163
163
Malposition of Device
158
158
Device Operates Differently Than Expected
150
150
Material Deformation
141
141
Nonstandard Device
139
139
Metal Shedding Debris
104
104
Device Contaminated During Manufacture or Shipping
97
97
Material Twisted/Bent
88
88
Use of Device Problem
88
88
Mechanical Problem
75
75
Unintended Movement
74
74
Connection Problem
72
72
Tear, Rip or Hole in Device Packaging
70
70
Patient Device Interaction Problem
66
66
Difficult to Remove
64
64
Positioning Failure
62
62
Device Markings/Labelling Problem
62
62
Inadequacy of Device Shape and/or Size
49
49
Crack
45
45
Device-Device Incompatibility
42
42
Incomplete or Inadequate Connection
42
42
No Apparent Adverse Event
40
40
Fitting Problem
40
40
Material Fragmentation
38
38
Mechanical Jam
35
35
Off-Label Use
34
34
Failure to Osseointegrate
31
31
Positioning Problem
31
31
Separation Failure
30
30
Defective Device
30
30
Patient-Device Incompatibility
28
28
Disassembly
28
28
Physical Resistance/Sticking
27
27
Device Inoperable
24
24
Device Slipped
23
23
Separation Problem
23
23
Material Integrity Problem
22
22
Device Damaged Prior to Use
20
20
Device Difficult to Setup or Prepare
19
19
Material Discolored
19
19
Delivered as Unsterile Product
17
17
Difficult To Position
17
17
Defective Component
17
17
Device Packaging Compromised
17
17
Difficult or Delayed Positioning
16
16
Premature Separation
16
16
Deformation Due to Compressive Stress
15
15
Device Damaged by Another Device
14
14
Device Contamination with Chemical or Other Material
14
14
Scratched Material
14
14
Device Appears to Trigger Rejection
14
14
Manufacturing, Packaging or Shipping Problem
12
12
Dull, Blunt
11
11
Improper or Incorrect Procedure or Method
11
11
Component Missing
11
11
Material Separation
10
10
Flaked
9
9
Inaccurate Information
9
9
Difficult or Delayed Separation
8
8
Illegible Information
7
7
Disconnection
7
7
Peeled/Delaminated
7
7
Contamination /Decontamination Problem
7
7
Failure to Advance
6
6
Unsealed Device Packaging
6
6
Detachment Of Device Component
6
6
Misassembled
6
6
Failure To Adhere Or Bond
5
5
Expiration Date Error
5
5
Activation, Positioning or Separation Problem
5
5
Difficult to Open or Remove Packaging Material
4
4
Compatibility Problem
4
4
Collapse
4
4
Misconnection
4
4
Entrapment of Device
4
4
Microbial Contamination of Device
4
4
Particulates
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
6496
6496
No Code Available
6368
6368
Joint Dislocation
3253
3253
Injury
3151
3151
Unspecified Infection
2858
2858
Test Result
1921
1921
Foreign Body Reaction
1678
1678
No Information
1572
1572
Inflammation
1554
1554
Tissue Damage
1306
1306
Discomfort
1160
1160
No Clinical Signs, Symptoms or Conditions
1069
1069
Reaction
1054
1054
Not Applicable
1028
1028
Osteolysis
999
999
Bone Fracture(s)
942
942
Failure of Implant
846
846
Inadequate Osseointegration
842
842
No Known Impact Or Consequence To Patient
775
775
No Consequences Or Impact To Patient
756
756
Ambulation Difficulties
746
746
Limited Mobility Of The Implanted Joint
713
713
Insufficient Information
689
689
Hypersensitivity/Allergic reaction
664
664
Metal Related Pathology
587
587
Loss of Range of Motion
569
569
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
529
529
Host-Tissue Reaction
395
395
Joint Laxity
372
372
Necrosis
353
353
Fall
335
335
Distress
325
325
Edema
282
282
Swelling
255
255
No Patient Involvement
245
245
Adhesion(s)
217
217
Weakness
216
216
Joint Disorder
212
212
Unspecified Tissue Injury
205
205
Hematoma
202
202
Swelling/ Edema
193
193
Ossification
193
193
Scar Tissue
189
189
Synovitis
165
165
Impaired Healing
139
139
Hip Fracture
133
133
Deformity/ Disfigurement
132
132
Wound Dehiscence
131
131
Fatigue
122
122
Cyst(s)
116
116
Thrombosis
113
113
Hemorrhage/Bleeding
113
113
Local Reaction
113
113
Pulmonary Embolism
112
112
Blood Loss
103
103
Anxiety
101
101
Osteopenia/ Osteoporosis
99
99
Bacterial Infection
95
95
Physical Asymmetry
91
91
Death
81
81
Muscular Rigidity
76
76
Nerve Damage
70
70
Fever
69
69
Fluid Discharge
60
60
Hypoesthesia
59
59
Depression
53
53
Sepsis
49
49
Fibrosis
47
47
Post Operative Wound Infection
43
43
Muscle/Tendon Damage
43
43
Abscess
43
43
Myocardial Infarction
42
42
Pocket Erosion
41
41
Rash
40
40
Numbness
40
40
Erosion
39
39
Cardiac Arrest
38
38
Headache
37
37
Erythema
37
37
Foreign Body In Patient
36
36
Limb Fracture
33
33
Thrombosis/Thrombus
31
31
Toxicity
31
31
Renal Failure
31
31
Anemia
30
30
Memory Loss/Impairment
28
28
Scarring
27
27
Unequal Limb Length
26
26
Infarction, Cerebral
26
26
Seroma
24
24
Tinnitus
24
24
Neuropathy
23
23
Reaction to Medicinal Component of Device
22
22
Stroke/CVA
22
22
Cellulitis
21
21
Calcium Deposits/Calcification
20
20
Device Embedded In Tissue or Plaque
20
20
Low Blood Pressure/ Hypotension
20
20
Pneumonia
19
19
Hearing Impairment
19
19
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
Howmedica Osteonics Corp.
II
Oct-11-2018
10
MicroPort Orthopedics Inc.
II
Jun-02-2022
11
Smith & Nephew, Inc.
II
May-09-2018
12
Zimmer Biomet, Inc.
II
Nov-02-2020
13
Zimmer Biomet, Inc.
II
Aug-09-2019
14
Zimmer Biomet, Inc.
II
Dec-04-2018
15
Zimmer Biomet, Inc.
II
Aug-14-2018
16
Zimmer Biomet, Inc.
II
Apr-27-2018
17
Zimmer Biomet, Inc.
II
Mar-14-2018
18
Zimmer Biomet, Inc.
II
Mar-14-2018
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