Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
378
378
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
8036
8036
Device Dislodged or Dislocated
1887
1887
Naturally Worn
1872
1872
Loss of Osseointegration
1033
1033
Insufficient Information
1026
1026
Fracture
609
609
Osseointegration Problem
605
605
Material Erosion
523
523
Device Contaminated During Manufacture or Shipping
520
520
Migration
462
462
Corroded
415
415
Use of Device Problem
355
355
Biocompatibility
320
320
Noise, Audible
307
307
Malposition of Device
290
290
Loosening of Implant Not Related to Bone-Ingrowth
226
226
Appropriate Term/Code Not Available
215
215
Degraded
205
205
Packaging Problem
178
178
Patient Device Interaction Problem
170
170
Loss of or Failure to Bond
168
168
Nonstandard Device
153
153
Material Disintegration
140
140
Tear, Rip or Hole in Device Packaging
137
137
Difficult to Insert
127
127
Unstable
116
116
Break
92
92
Manufacturing, Packaging or Shipping Problem
77
77
Patient-Device Incompatibility
71
71
Detachment of Device or Device Component
66
66
Unintended Movement
66
66
Difficult to Remove
65
65
Inadequacy of Device Shape and/or Size
61
61
Device-Device Incompatibility
59
59
Loose or Intermittent Connection
51
51
Positioning Failure
50
50
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
Material Integrity Problem
21
21
Mechanical 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
7202
7202
Foreign Body Reaction
2970
2970
Test Result
2243
2243
Unspecified Infection
2099
2100
Joint Dislocation
1479
1479
Osteolysis
1479
1479
Metal Related Pathology
1337
1337
Inadequate Osseointegration
1290
1290
Tissue Damage
1286
1286
Hypersensitivity/Allergic reaction
1176
1176
Discomfort
1141
1141
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)
711
711
Loss of Range of Motion
628
628
Inflammation
600
600
No Clinical Signs, Symptoms or Conditions
546
546
Insufficient Information
539
539
Necrosis
515
515
Ambulation Difficulties
484
484
Reaction
472
472
Edema
465
465
Swelling/ Edema
458
458
Failure of Implant
451
451
Distress
444
444
Unspecified Tissue Injury
389
389
No Patient Involvement
375
375
Adhesion(s)
372
372
No Known Impact Or Consequence To Patient
335
335
Scar Tissue
270
270
Synovitis
265
265
Joint Laxity
260
260
Deformity/ Disfigurement
252
252
Cyst(s)
234
234
Anxiety
226
226
No Consequences Or Impact To Patient
226
226
Fatigue
223
223
Swelling
208
208
Weakness
201
201
Fall
196
196
Not Applicable
186
186
Local Reaction
185
185
Host-Tissue Reaction
177
177
Ossification
161
161
Hematoma
145
145
Thrombosis
143
143
Muscular Rigidity
129
129
Hemorrhage/Bleeding
125
125
Muscle/Tendon Damage
123
123
Pulmonary Embolism
122
122
Depression
112
112
Physical Asymmetry
96
96
Osteopenia/ Osteoporosis
92
92
Pocket Erosion
86
86
Joint Disorder
80
80
Nerve Damage
69
69
Numbness
67
67
Wound Dehiscence
62
62
Erosion
59
59
Fibrosis
51
51
Abscess
48
48
Cardiac Arrest
45
45
Memory Loss/Impairment
45
45
Myocardial Infarction
44
44
Blood Loss
44
44
Hypoesthesia
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
Renal Failure
34
34
Scarring
33
33
Toxicity
32
32
Headache
31
31
Hearing Impairment
30
30
Impaired Healing
30
30
Infarction, Cerebral
29
29
Bacterial Infection
27
27
Tinnitus
26
26
Dizziness
25
25
Calcium Deposits/Calcification
25
25
Foreign Body In Patient
25
25
Thrombosis/Thrombus
24
24
Unspecified Musculoskeletal problem
23
23
Post Operative Wound Infection
22
22
Anemia
21
21
Dyspnea
20
20
Heart Failure
19
19
Itching Sensation
19
19
Arthralgia
19
19
Unequal Limb Length
18
18
Erythema
18
18
Atrial Fibrillation
18
18
Pneumonia
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
-
-