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Device
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Regulation Description
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Product Code
KWA
Regulation Number
888.3330
Device Class
3
MDR Year
MDR Reports
MDR Events
2016
7863
7863
2017
6839
6839
2018
6377
6377
2019
7626
7626
2020
4544
4544
2021
254
254
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
10114
10114
Adverse Event Without Identified Device or Use Problem
7197
7197
Appropriate Term/Code Not Available
4591
4591
Naturally Worn
3127
3127
Device Dislodged or Dislocated
2735
2735
Loss of Osseointegration
1918
1918
Metal Shedding Debris
1314
1314
Material Erosion
1111
1111
Corroded
1096
1096
Migration or Expulsion of Device
744
744
Fracture
737
737
Noise, Audible
689
689
Malposition of Device
590
590
Device Contaminated During Manufacture or Shipping
539
539
Osseointegration Problem
505
505
Material Disintegration
501
501
Nonstandard Device
436
436
Migration
431
431
Loose or Intermittent Connection
407
407
Use of Device Problem
300
300
Biocompatibility
293
293
Break
292
292
Loss of or Failure to Bond
236
236
Unstable
225
225
Degraded
213
213
Disassembly
174
174
Difficult to Remove
133
133
Loosening of Implant Not Related to Bone-Ingrowth
132
132
Packaging Problem
115
115
Tear, Rip or Hole in Device Packaging
113
113
Separation Failure
94
94
Device Operates Differently Than Expected
88
88
Inadequacy of Device Shape and/or Size
81
81
Device Packaging Compromised
73
73
Difficult to Insert
71
71
Compatibility Problem
66
66
Unintended Movement
65
65
Failure to Osseointegrate
64
64
Device-Device Incompatibility
63
63
Detachment of Device or Device Component
61
61
Patient-Device Incompatibility
60
60
Mechanical Problem
59
59
Positioning Problem
53
53
Fitting Problem
43
43
Device Contamination with Chemical or Other Material
40
40
Positioning Failure
40
40
Device Slipped
39
39
Separation Problem
36
36
No Apparent Adverse Event
35
35
Failure To Adhere Or Bond
35
35
Material Deformation
27
27
Material Separation
23
23
Material Integrity Problem
20
20
Delivered as Unsterile Product
19
19
Disconnection
17
17
Difficult To Position
17
17
Mechanical Jam
16
16
Detachment Of Device Component
16
16
Scratched Material
16
16
Material Twisted/Bent
15
15
Defective Device
15
15
Component Missing
15
15
Off-Label Use
14
14
Material Discolored
13
13
Difficult or Delayed Separation
12
12
Patient Device Interaction Problem
10
10
Problem with Sterilization
10
10
Crack
10
10
Device Markings/Labelling Problem
10
10
Improper or Incorrect Procedure or Method
9
9
Material Fragmentation
9
9
Component or Accessory Incompatibility
9
9
Unsealed Device Packaging
7
7
Peeled/Delaminated
7
7
Entrapment of Device
7
7
Connection Problem
6
6
Failure to Disconnect
6
6
Manufacturing, Packaging or Shipping Problem
5
5
Improper Chemical Reaction
5
5
Flaked
5
5
Shipping Damage or Problem
5
5
Cup
4
4
Bent
4
4
Collapse
4
4
Expiration Date Error
4
4
Defective Component
4
4
Physical Resistance/Sticking
3
3
Biofilm coating in Device
3
3
Device Damaged Prior to Use
3
3
Fluid Leak
3
3
Illegible Information
3
3
Inaccurate Information
2
2
Therapeutic or Diagnostic Output Failure
2
2
Device Abrasion From Instrument Or Another Object
2
2
Component Incompatible
2
2
Screw
2
2
Device Damaged by Another Device
2
2
Physical Property Issue
2
2
Computer Operating System Problem
2
2
Device Or Device Fragments Location Unknown
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
15577
15578
No Code Available
12139
12141
No Information
4656
4656
Foreign Body Reaction
4100
4100
Test Result
3143
3143
Discomfort
3112
3112
Unspecified Infection
2866
2867
Tissue Damage
2800
2800
Reaction
2461
2461
Host-Tissue Reaction
2322
2322
Osteolysis
2277
2277
Injury
2246
2246
Joint Dislocation
2021
2021
Limited Mobility Of The Implanted Joint
1888
1888
Not Applicable
1593
1593
Inadequate Osseointegration
1529
1530
Inflammation
1481
1481
Hypersensitivity/Allergic reaction
1124
1124
Bone Fracture(s)
1113
1113
Loss of Range of Motion
936
936
Ambulation Difficulties
737
737
Necrosis
680
680
Weakness
658
658
Edema
649
649
Swelling
625
625
No Known Impact Or Consequence To Patient
567
567
No Consequences Or Impact To Patient
525
525
Distress
525
525
No Patient Involvement
512
512
Cyst(s)
401
401
Synovitis
399
399
Adhesion(s)
347
347
Anxiety
277
277
Toxicity
270
270
Local Reaction
253
253
Muscular Rigidity
230
230
Hematoma
211
211
Scar Tissue
209
209
Fall
206
206
Ossification
199
199
Failure of Implant
198
198
Fatigue
187
187
Fluid Discharge
183
183
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
179
179
Thrombosis
176
176
Joint Disorder
171
171
Deformity/ Disfigurement
166
166
Hip Fracture
145
145
Blood Loss
140
140
Pulmonary Embolism
138
138
Death
107
107
Hemorrhage/Bleeding
99
99
Depression
94
94
Erosion
92
92
Fibrosis
87
87
Scarring
84
84
Hypoesthesia
80
80
Wound Dehiscence
76
76
Nerve Damage
76
76
Joint Swelling
76
76
Osteopenia/ Osteoporosis
68
68
Pocket Erosion
66
66
Cardiac Arrest
65
65
Infarction, Cerebral
60
60
Irritation
59
59
Sepsis
56
56
Fever
56
56
Insufficient Information
54
54
Myocardial Infarction
54
54
Headache
51
51
Rash
47
47
Abscess
46
46
Skin Irritation
45
45
Impaired Healing
40
40
Calcium Deposits/Calcification
39
39
Numbness
37
37
Hearing Impairment
35
35
Memory Loss/Impairment
35
35
Complaint, Ill-Defined
35
35
Foreign Body In Patient
34
34
Metal Related Pathology
34
34
Stroke/CVA
33
33
Nausea
31
31
Tinnitus
30
30
Post Operative Wound Infection
30
30
Renal Failure
30
30
Anemia
27
27
Burning Sensation
27
27
Unspecified Tissue Injury
26
26
Heart Failure
25
25
Swelling/ Edema
23
23
Patient Problem/Medical Problem
23
23
Bacterial Infection
23
23
Neuropathy
23
23
Muscle Spasm(s)
23
23
Sleep Dysfunction
22
22
Malaise
22
22
Itching Sensation
22
22
Purulent Discharge
20
20
Cognitive Changes
20
20
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Jan-07-2021
2
Encore Medical, Lp
II
Feb-11-2017
3
Zimmer Biomet, Inc.
II
Nov-07-2019
4
Zimmer Biomet, Inc.
II
Dec-19-2018
5
Zimmer Biomet, Inc.
II
Aug-14-2018
6
Zimmer Biomet, Inc.
II
Dec-29-2017
7
Zimmer Biomet, Inc.
II
Feb-22-2016
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