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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
2019
7633
7633
2020
4536
4536
2021
2063
2063
2022
1620
1620
2023
1478
1478
2024
166
166
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7898
7898
Device Dislodged or Dislocated
1876
1876
Naturally Worn
1859
1859
Loss of Osseointegration
1031
1031
Insufficient Information
1022
1022
Fracture
602
602
Osseointegration Problem
595
595
Device Contaminated During Manufacture or Shipping
520
520
Material Erosion
517
517
Migration
456
456
Corroded
415
415
Use of Device Problem
354
354
Biocompatibility
320
320
Noise, Audible
305
305
Malposition of Device
290
290
Loosening of Implant Not Related to Bone-Ingrowth
220
220
Appropriate Term/Code Not Available
215
215
Degraded
204
204
Packaging Problem
178
178
Patient Device Interaction Problem
170
170
Loss of or Failure to Bond
167
167
Nonstandard Device
153
153
Material Disintegration
140
140
Tear, Rip or Hole in Device Packaging
136
136
Difficult to Insert
123
123
Unstable
114
114
Break
92
92
Manufacturing, Packaging or Shipping Problem
74
74
Patient-Device Incompatibility
69
69
Unintended Movement
66
66
Detachment of Device or Device Component
64
64
Difficult to Remove
63
63
Inadequacy of Device Shape and/or Size
60
60
Device-Device Incompatibility
59
59
Loose or Intermittent Connection
51
51
Positioning Failure
49
49
Separation Failure
36
36
No Apparent Adverse Event
36
36
Failure to Osseointegrate
32
32
Off-Label Use
31
31
Migration or Expulsion of Device
27
27
Mechanical Problem
20
20
Material Integrity Problem
20
20
Delivered as Unsterile Product
17
17
Mechanical Jam
15
15
Separation Problem
15
15
Material Twisted/Bent
14
14
Positioning Problem
13
13
Material Deformation
13
13
Physical Resistance/Sticking
13
13
Fitting Problem
13
13
Difficult or Delayed Separation
11
11
Scratched Material
10
10
Problem with Sterilization
10
10
Improper or Incorrect Procedure or Method
9
9
Flaked
8
8
Material Fragmentation
8
8
Illegible Information
8
8
Inaccurate Information
7
7
Output Problem
7
7
Unsealed Device Packaging
7
7
Shipping Damage or Problem
7
7
Material Separation
6
6
Defective Device
6
6
Contamination /Decontamination Problem
6
6
Expiration Date Error
5
5
Difficult or Delayed Positioning
5
5
Difficult to Open or Remove Packaging Material
5
5
Missing Information
4
4
Peeled/Delaminated
4
4
Device Markings/Labelling Problem
4
4
Device Damaged Prior to Use
4
4
Difficult to Advance
3
3
Activation, Positioning or Separation Problem
3
3
Biofilm coating in Device
3
3
Misassembled
3
3
Material Discolored
3
3
Entrapment of Device
3
3
Therapeutic or Diagnostic Output Failure
3
3
Human-Device Interface Problem
2
2
Disconnection
2
2
Crack
2
2
Collapse
2
2
Device Difficult to Setup or Prepare
2
2
Device Appears to Trigger Rejection
2
2
Failure to Disconnect
2
2
Connection Problem
2
2
Defective Component
2
2
Component Missing
2
2
Incomplete or Missing Packaging
2
2
Failure to Align
1
1
Microbial Contamination of Device
1
1
Vibration
1
1
Device Slipped
1
1
Failure to Fire
1
1
Device Ingredient or Reagent Problem
1
1
Device Damaged by Another Device
1
1
Particulates
1
1
Component Incompatible
1
1
Contamination
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
7827
7829
Pain
7136
7136
Foreign Body Reaction
2898
2898
Test Result
2243
2243
Unspecified Infection
2080
2081
Joint Dislocation
1471
1471
Osteolysis
1468
1468
Metal Related Pathology
1297
1297
Tissue Damage
1286
1286
Inadequate Osseointegration
1280
1280
Discomfort
1132
1132
Hypersensitivity/Allergic reaction
1116
1116
Injury
850
850
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
837
837
No Information
740
740
Limited Mobility Of The Implanted Joint
729
729
Bone Fracture(s)
700
700
Loss of Range of Motion
624
624
Inflammation
593
593
No Clinical Signs, Symptoms or Conditions
534
534
Necrosis
514
514
Insufficient Information
513
513
Ambulation Difficulties
482
482
Reaction
472
472
Edema
465
465
Swelling/ Edema
445
445
Distress
444
444
Failure of Implant
443
443
Unspecified Tissue Injury
379
379
No Patient Involvement
375
375
Adhesion(s)
371
371
No Known Impact Or Consequence To Patient
335
335
Scar Tissue
266
266
Synovitis
256
256
Deformity/ Disfigurement
252
252
Joint Laxity
245
245
Cyst(s)
230
230
Anxiety
226
226
No Consequences Or Impact To Patient
226
226
Fatigue
218
218
Swelling
208
208
Weakness
201
201
Fall
187
187
Not Applicable
186
186
Local Reaction
185
185
Host-Tissue Reaction
177
177
Ossification
157
157
Hematoma
145
145
Thrombosis
143
143
Muscular Rigidity
123
123
Hemorrhage/Bleeding
123
123
Pulmonary Embolism
122
122
Muscle/Tendon Damage
121
121
Depression
111
111
Physical Asymmetry
96
96
Osteopenia/ Osteoporosis
89
89
Pocket Erosion
86
86
Joint Disorder
80
80
Nerve Damage
69
69
Numbness
62
62
Wound Dehiscence
61
61
Erosion
59
59
Fibrosis
51
51
Cardiac Arrest
45
45
Abscess
45
45
Memory Loss/Impairment
45
45
Blood Loss
44
44
Hypoesthesia
43
43
Myocardial Infarction
43
43
Rash
42
42
Fever
42
42
Sepsis
41
41
Fluid Discharge
40
40
Death
38
38
Limb Fracture
37
37
Stroke/CVA
35
35
Scarring
33
33
Toxicity
32
32
Renal Failure
31
31
Headache
31
31
Hearing Impairment
30
30
Infarction, Cerebral
29
29
Impaired Healing
29
29
Tinnitus
26
26
Dizziness
25
25
Bacterial Infection
25
25
Calcium Deposits/Calcification
25
25
Foreign Body In Patient
24
24
Thrombosis/Thrombus
24
24
Post Operative Wound Infection
22
22
Unspecified Musculoskeletal problem
22
22
Anemia
21
21
Dyspnea
20
20
Heart Failure
19
19
Itching Sensation
19
19
Arthralgia
19
19
Erythema
18
18
Atrial Fibrillation
18
18
Pneumonia
17
17
Hip Fracture
17
17
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Nov-21-2023
2
Biomet, Inc.
II
Aug-12-2021
3
DePuy Orthopaedics, Inc.
II
Jan-07-2021
4
Encore Medical, LP
II
Sep-19-2023
5
Zimmer Biomet, Inc.
II
Nov-07-2019
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