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TPLC
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Device
prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Product Code
KWZ
Regulation Number
888.3310
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
1. K240639
PINNACLETM Constrained Acetabular Liners
MDR Year
MDR Reports
MDR Events
2019
533
533
2020
288
288
2021
216
216
2022
158
158
2023
164
164
2024
31
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
594
594
Adverse Event Without Identified Device or Use Problem
298
298
Naturally Worn
128
128
Fracture
115
115
Device Contaminated During Manufacture or Shipping
68
68
Insufficient Information
55
55
Appropriate Term/Code Not Available
48
48
Detachment of Device or Device Component
43
43
Difficult to Insert
29
29
Unstable
24
24
Break
22
22
Noise, Audible
16
16
Packaging Problem
15
15
Positioning Failure
12
12
Off-Label Use
11
11
Loose or Intermittent Connection
11
11
Material Deformation
11
11
Loosening of Implant Not Related to Bone-Ingrowth
11
11
Nonstandard Device
10
10
Scratched Material
9
9
Unintended Movement
8
8
Device-Device Incompatibility
8
8
Migration
7
7
Separation Failure
7
7
Malposition of Device
7
7
Tear, Rip or Hole in Device Packaging
6
6
Material Erosion
6
6
Loss of or Failure to Bond
6
6
Difficult to Remove
5
5
Loss of Osseointegration
5
5
Biocompatibility
5
5
Use of Device Problem
5
5
Inadequacy of Device Shape and/or Size
5
5
Fitting Problem
5
5
Mechanical Problem
4
4
Patient Device Interaction Problem
4
4
Connection Problem
3
3
Material Twisted/Bent
3
3
Device Difficult to Setup or Prepare
3
3
Shipping Damage or Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Failure to Osseointegrate
2
2
Deformation Due to Compressive Stress
2
2
Contamination /Decontamination Problem
2
2
Defective Device
2
2
Material Separation
2
2
Degraded
2
2
Corroded
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Osseointegration Problem
2
2
Component Missing
2
2
Difficult to Open or Close
2
2
Illegible Information
2
2
Physical Resistance/Sticking
1
1
Difficult or Delayed Separation
1
1
No Apparent Adverse Event
1
1
Therapeutic or Diagnostic Output Failure
1
1
Excessive Cooling
1
1
Device Contamination with Chemical or Other Material
1
1
Device Damaged by Another Device
1
1
Positioning Problem
1
1
Mechanical Jam
1
1
Crack
1
1
Delivered as Unsterile Product
1
1
Material Disintegration
1
1
Problem with Sterilization
1
1
Defective Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Joint Dislocation
512
512
No Code Available
431
431
Pain
202
202
Unspecified Infection
141
141
Injury
97
97
Insufficient Information
78
78
No Clinical Signs, Symptoms or Conditions
78
78
Osteolysis
57
57
No Patient Involvement
56
56
Foreign Body Reaction
54
54
No Information
43
43
Joint Laxity
42
42
Failure of Implant
40
40
Fall
38
38
No Known Impact Or Consequence To Patient
38
38
No Consequences Or Impact To Patient
33
33
Tissue Damage
32
32
Test Result
32
32
Ambulation Difficulties
29
29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
28
28
Limited Mobility Of The Implanted Joint
26
26
Loss of Range of Motion
23
23
Hypersensitivity/Allergic reaction
23
23
Bone Fracture(s)
20
20
Discomfort
17
17
Not Applicable
17
17
Hematoma
14
14
Inflammation
11
11
Ossification
11
11
Scar Tissue
11
11
Osteopenia/ Osteoporosis
11
11
Adhesion(s)
10
10
Edema
10
10
Thrombosis
9
9
Inadequate Osseointegration
9
9
Joint Disorder
7
7
Metal Related Pathology
7
7
Unspecified Tissue Injury
7
7
Swelling
7
7
Necrosis
7
7
Weakness
7
7
Pulmonary Embolism
7
7
Cyst(s)
6
6
Fatigue
6
6
Impaired Healing
6
6
Reaction
6
6
Swelling/ Edema
5
5
Unspecified Musculoskeletal problem
4
4
Hemorrhage/Bleeding
4
4
Erosion
4
4
Wound Dehiscence
4
4
Host-Tissue Reaction
3
3
Cardiac Arrest
3
3
Infarction, Cerebral
3
3
Death
3
3
Anxiety
3
3
Distress
3
3
Hip Fracture
3
3
Patient Problem/Medical Problem
3
3
Muscle/Tendon Damage
3
3
Thrombosis/Thrombus
2
2
Limb Fracture
2
2
Physical Asymmetry
2
2
Respiratory Distress
2
2
Arthralgia
2
2
Nerve Damage
2
2
Nausea
2
2
Synovitis
2
2
Scarring
2
2
Seroma
2
2
Skin Discoloration
1
1
Thrombus
1
1
Local Reaction
1
1
Renal Failure
1
1
Pocket Erosion
1
1
Deformity/ Disfigurement
1
1
Blood Loss
1
1
Numbness
1
1
Hypoesthesia
1
1
Erythema
1
1
Bruise/Contusion
1
1
Calcium Deposits/Calcification
1
1
Abscess
1
1
Anemia
1
1
Arrhythmia
1
1
Arthritis
1
1
Atrial Fibrillation
1
1
Headache
1
1
Hearing Impairment
1
1
Itching Sensation
1
1
Muscle Weakness
1
1
Muscular Rigidity
1
1
High Blood Pressure/ Hypertension
1
1
Infiltration into Tissue
1
1
Implant Pain
1
1
Subluxation
1
1
Unequal Limb Length
1
1
Fluid Discharge
1
1
Fibrosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Encore Medical, Lp
II
Apr-10-2019
2
Exactech, Inc.
II
Jan-18-2024
3
Exactech, Inc.
II
Sep-09-2022
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