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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
6388
6388
2019
7632
7632
2020
4535
4535
2021
2060
2060
2022
1623
1623
2023
1074
1074
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
8754
8754
Insufficient Information
3281
3281
Naturally Worn
2440
2440
Device Dislodged or Dislocated
2244
2244
Loss of Osseointegration
1196
1196
Appropriate Term/Code Not Available
1105
1105
Material Erosion
805
805
Fracture
726
726
Osseointegration Problem
642
642
Corroded
634
634
Device Contaminated During Manufacture or Shipping
561
561
Migration
507
507
Noise, Audible
400
400
Malposition of Device
373
373
Use of Device Problem
352
352
Biocompatibility
340
340
Material Disintegration
274
274
Migration or Expulsion of Device
242
242
Degraded
239
239
Nonstandard Device
234
234
Loosening of Implant Not Related to Bone-Ingrowth
229
229
Packaging Problem
201
201
Loss of or Failure to Bond
190
190
Loose or Intermittent Connection
182
182
Unstable
171
171
Tear, Rip or Hole in Device Packaging
167
167
Patient Device Interaction Problem
167
167
Metal Shedding Debris
163
163
Break
147
147
Difficult to Insert
120
120
Difficult to Remove
90
90
Detachment of Device or Device Component
79
79
Inadequacy of Device Shape and/or Size
76
76
Separation Failure
75
75
Patient-Device Incompatibility
73
73
Device-Device Incompatibility
72
72
Unintended Movement
68
68
Manufacturing, Packaging or Shipping Problem
62
62
Device Packaging Compromised
58
58
Disassembly
58
58
Failure to Osseointegrate
57
57
Positioning Failure
49
49
No Apparent Adverse Event
46
46
Device Contamination with Chemical or Other Material
36
36
Separation Problem
36
36
Off-Label Use
31
31
Fitting Problem
30
30
Material Deformation
26
26
Material Integrity Problem
22
22
Positioning Problem
21
21
Delivered as Unsterile Product
20
20
Mechanical Problem
19
19
Material Twisted/Bent
17
17
Mechanical Jam
17
17
Disconnection
16
16
Material Separation
16
16
Physical Resistance/Sticking
12
12
Difficult or Delayed Separation
11
11
Scratched Material
11
11
Problem with Sterilization
10
10
Improper or Incorrect Procedure or Method
10
10
Material Fragmentation
10
10
Flaked
9
9
Unsealed Device Packaging
9
9
Failure To Adhere Or Bond
9
9
Defective Device
8
8
Difficult To Position
8
8
Illegible Information
8
8
Inaccurate Information
7
7
Output Problem
7
7
Device Markings/Labelling Problem
7
7
Peeled/Delaminated
7
7
Shipping Damage or Problem
7
7
Material Discolored
7
7
Contamination /Decontamination Problem
6
6
Connection Problem
5
5
Device Operates Differently Than Expected
5
5
Difficult to Open or Remove Packaging Material
5
5
Difficult or Delayed Positioning
5
5
Crack
5
5
Expiration Date Error
5
5
Component Missing
5
5
Device Damaged Prior to Use
4
4
Misassembled
4
4
Missing Information
4
4
Difficult to Advance
3
3
Activation, Positioning or Separation Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Entrapment of Device
3
3
Biofilm coating in Device
3
3
Defective Component
3
3
Incomplete or Missing Packaging
3
3
Failure to Disconnect
3
3
Device Slipped
3
3
Device Difficult to Setup or Prepare
2
2
Device Appears to Trigger Rejection
2
2
Material Rupture
2
2
Dull, Blunt
2
2
Failure to Align
2
2
Bent
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
9907
9908
No Code Available
9468
9470
Foreign Body Reaction
3243
3243
Test Result
3014
3014
Unspecified Infection
2555
2556
Tissue Damage
2119
2119
Joint Dislocation
1811
1811
Osteolysis
1795
1795
Discomfort
1795
1795
Injury
1682
1682
Inadequate Osseointegration
1577
1578
No Information
1398
1398
Not Applicable
1369
1369
Hypersensitivity/Allergic reaction
1286
1286
Metal Related Pathology
1206
1206
Limited Mobility Of The Implanted Joint
1204
1204
Reaction
1100
1100
Inflammation
958
958
Bone Fracture(s)
900
900
Loss of Range of Motion
881
881
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
874
874
Distress
760
760
Ambulation Difficulties
651
651
Necrosis
647
647
Host-Tissue Reaction
614
614
Edema
584
584
No Patient Involvement
503
503
No Clinical Signs, Symptoms or Conditions
475
475
Adhesion(s)
459
459
Insufficient Information
454
454
Failure of Implant
444
444
No Consequences Or Impact To Patient
428
428
No Known Impact Or Consequence To Patient
424
424
Weakness
418
418
Swelling/ Edema
405
405
Swelling
367
367
Unspecified Tissue Injury
358
358
Anxiety
330
330
Cyst(s)
326
326
Scar Tissue
321
321
Deformity/ Disfigurement
317
317
Synovitis
315
315
Fatigue
258
258
Local Reaction
239
239
Joint Laxity
225
225
Fall
216
216
Ossification
191
191
Hematoma
187
187
Muscular Rigidity
168
168
Thrombosis
166
166
Pulmonary Embolism
139
139
Depression
136
136
Blood Loss
129
129
Joint Disorder
127
127
Hemorrhage/Bleeding
126
126
Osteopenia/ Osteoporosis
101
101
Physical Asymmetry
94
94
Pocket Erosion
94
94
Muscle/Tendon Damage
90
90
Fibrosis
79
79
Nerve Damage
79
79
Erosion
77
77
Wound Dehiscence
74
74
Hip Fracture
66
66
Numbness
64
64
Fluid Discharge
62
62
Cardiac Arrest
60
60
Hypoesthesia
59
59
Death
56
56
Fever
54
54
Scarring
54
54
Memory Loss/Impairment
53
53
Abscess
53
53
Toxicity
53
53
Impaired Healing
51
51
Rash
51
51
Sepsis
51
51
Myocardial Infarction
48
48
Infarction, Cerebral
44
44
Bacterial Infection
41
41
Headache
41
41
Stroke/CVA
39
39
Post Operative Wound Infection
39
39
Calcium Deposits/Calcification
37
37
Renal Failure
36
36
Limb Fracture
36
36
Foreign Body In Patient
35
35
Tinnitus
32
32
Hearing Impairment
32
32
Anemia
29
29
Confusion/ Disorientation
27
27
Dizziness
24
24
Burning Sensation
23
23
Heart Failure
22
22
Thrombosis/Thrombus
22
22
Unspecified Musculoskeletal problem
21
21
Arthralgia
20
20
Neuropathy
20
20
Nausea
20
20
Itching Sensation
20
20
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Aug-12-2021
2
DePuy Orthopaedics, Inc.
II
Jan-07-2021
3
Encore Medical, LP
II
Sep-19-2023
4
Zimmer Biomet, Inc.
II
Nov-07-2019
5
Zimmer Biomet, Inc.
II
Dec-19-2018
6
Zimmer Biomet, Inc.
II
Aug-14-2018
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