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TPLC
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Device
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Product Code
KWA
Regulation Number
888.3330
Device Class
3
MDR Year
MDR Reports
MDR Events
2018
6394
6394
2019
7640
7640
2020
4545
4545
2021
2079
2079
2022
1675
1675
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
8210
8210
Insufficient Information
3282
3282
Naturally Worn
2321
2321
Device Dislodged or Dislocated
2159
2159
Loss of Osseointegration
1195
1195
Appropriate Term/Code Not Available
1107
1107
Material Erosion
789
789
Fracture
683
683
Corroded
621
621
Osseointegration Problem
606
606
Device Contaminated During Manufacture or Shipping
560
560
Migration
501
501
Malposition of Device
376
376
Noise, Audible
373
373
Use of Device Problem
330
330
Biocompatibility
311
311
Material Disintegration
274
274
Migration or Expulsion of Device
242
242
Nonstandard Device
233
233
Degraded
223
223
Loosening of Implant Not Related to Bone-Ingrowth
208
208
Loss of or Failure to Bond
191
191
Packaging Problem
186
186
Loose or Intermittent Connection
182
182
Unstable
169
169
Metal Shedding Debris
163
163
Tear, Rip or Hole in Device Packaging
160
160
Break
146
146
Patient Device Interaction Problem
113
113
Difficult to Insert
105
105
Difficult to Remove
83
83
Detachment of Device or Device Component
79
79
Separation Failure
75
75
Device-Device Incompatibility
73
73
Inadequacy of Device Shape and/or Size
71
71
Unintended Movement
69
69
Device Packaging Compromised
58
58
Disassembly
58
58
Failure to Osseointegrate
57
57
Patient-Device Incompatibility
53
53
Positioning Failure
47
47
No Apparent Adverse Event
43
43
Device Contamination with Chemical or Other Material
36
36
Separation Problem
36
36
Manufacturing, Packaging or Shipping Problem
32
32
Fitting Problem
30
30
Off-Label Use
28
28
Material Deformation
26
26
Material Integrity Problem
24
24
Positioning Problem
20
20
Mechanical Problem
19
19
Delivered as Unsterile Product
19
19
Material Separation
17
17
Material Twisted/Bent
17
17
Mechanical Jam
17
17
Disconnection
16
16
Scratched Material
11
11
Difficult or Delayed Separation
11
11
Material Fragmentation
10
10
Problem with Sterilization
10
10
Improper or Incorrect Procedure or Method
9
9
Flaked
9
9
Unsealed Device Packaging
9
9
Failure To Adhere Or Bond
9
9
Difficult To Position
8
8
Defective Device
8
8
Output Problem
8
8
Device Markings/Labelling Problem
7
7
Illegible Information
7
7
Physical Resistance/Sticking
7
7
Shipping Damage or Problem
7
7
Material Discolored
7
7
Peeled/Delaminated
6
6
Inaccurate Information
6
6
Contamination /Decontamination Problem
6
6
Difficult to Open or Remove Packaging Material
6
6
Connection Problem
5
5
Device Operates Differently Than Expected
5
5
Expiration Date Error
5
5
Component Missing
5
5
Difficult or Delayed Positioning
5
5
Crack
5
5
Misassembled
4
4
Device Damaged Prior to Use
4
4
Therapeutic or Diagnostic Output Failure
4
4
Activation, Positioning or Separation Problem
3
3
Difficult to Advance
3
3
Missing Information
3
3
Defective Component
3
3
Incomplete or Missing Packaging
3
3
Failure to Disconnect
3
3
Device Slipped
3
3
Entrapment of Device
3
3
Biofilm coating in Device
3
3
Bent
2
2
Collapse
2
2
Device Difficult to Setup or Prepare
2
2
Material Rupture
2
2
Failure to Align
2
2
Dull, Blunt
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
9483
9485
Pain
9445
9446
Test Result
3019
3019
Foreign Body Reaction
2950
2950
Unspecified Infection
2424
2425
Tissue Damage
2122
2122
Joint Dislocation
1740
1740
Osteolysis
1701
1701
Injury
1686
1686
Discomfort
1671
1671
Inadequate Osseointegration
1546
1547
No Information
1401
1401
Not Applicable
1371
1371
Limited Mobility Of The Implanted Joint
1206
1206
Hypersensitivity/Allergic reaction
1183
1183
Reaction
1104
1104
Inflammation
910
910
Bone Fracture(s)
887
887
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
875
875
Loss of Range of Motion
793
793
Metal Related Pathology
766
766
Distress
651
651
Host-Tissue Reaction
615
615
Necrosis
602
602
Edema
585
585
Ambulation Difficulties
555
555
No Patient Involvement
503
503
No Consequences Or Impact To Patient
428
428
No Known Impact Or Consequence To Patient
424
424
Weakness
420
420
Adhesion(s)
411
411
Insufficient Information
394
394
No Clinical Signs, Symptoms or Conditions
380
380
Failure of Implant
368
368
Swelling
367
367
Cyst(s)
310
310
Swelling/ Edema
309
309
Scar Tissue
266
266
Anxiety
263
263
Synovitis
256
256
Deformity/ Disfigurement
254
254
Local Reaction
243
243
Unspecified Tissue Injury
231
231
Fatigue
215
215
Fall
199
199
Hematoma
186
186
Ossification
177
177
Joint Laxity
173
173
Thrombosis
166
166
Muscular Rigidity
153
153
Pulmonary Embolism
141
141
Blood Loss
129
129
Joint Disorder
127
127
Hemorrhage/Bleeding
119
119
Osteopenia/ Osteoporosis
99
99
Depression
94
94
Erosion
79
79
Pocket Erosion
76
76
Fibrosis
70
70
Wound Dehiscence
69
69
Nerve Damage
66
66
Hip Fracture
66
66
Physical Asymmetry
66
66
Cardiac Arrest
60
60
Hypoesthesia
59
59
Fluid Discharge
56
56
Muscle/Tendon Damage
56
56
Death
56
56
Scarring
54
54
Impaired Healing
54
54
Toxicity
53
53
Abscess
51
51
Sepsis
49
49
Rash
49
49
Myocardial Infarction
48
48
Fever
47
47
Infarction, Cerebral
44
44
Post Operative Wound Infection
42
42
Stroke/CVA
39
39
Headache
38
38
Calcium Deposits/Calcification
37
37
Numbness
37
37
Memory Loss/Impairment
35
35
Bacterial Infection
34
34
Renal Failure
33
33
Hearing Impairment
32
32
Foreign Body In Patient
32
32
Limb Fracture
30
30
Tinnitus
30
30
Anemia
26
26
Dizziness
23
23
Burning Sensation
23
23
Heart Failure
22
22
Nausea
21
21
Neuropathy
20
20
Itching Sensation
20
20
Atrial Fibrillation
20
20
Dyspnea
20
20
Arthralgia
20
20
Thrombosis/Thrombus
19
19
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Aug-12-2021
2
DePuy Orthopaedics, Inc.
II
Jan-07-2021
3
Zimmer Biomet, Inc.
II
Nov-07-2019
4
Zimmer Biomet, Inc.
II
Dec-19-2018
5
Zimmer Biomet, Inc.
II
Aug-14-2018
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