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TPLC
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Device
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
Product Code
MAY
Regulation Number
888.3353
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMET, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K090103
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFIL
...
HOWMEDICA OSTEONICS CORP
SUBSTANTIALLY EQUIVALENT
1
STRYKER CORP.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
94
94
2015
115
115
2016
60
60
2017
33
33
2018
33
33
2019
11
11
2020
14
14
2021
24
24
2022
11
11
2023
8
8
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
81
81
Insufficient Information
70
70
Break
67
67
Device Dislodged or Dislocated
47
47
Adverse Event Without Identified Device or Use Problem
40
40
Material Integrity Problem
22
22
Detachment Of Device Component
15
15
Device Slipped
14
14
Naturally Worn
13
13
Mechanical Problem
12
12
Unstable
11
11
Device Operates Differently Than Expected
11
11
Appropriate Term/Code Not Available
11
11
Material Deformation
10
10
Difficult to Remove
9
9
Fitting Problem
8
8
Noise, Audible
8
8
Loose or Intermittent Connection
8
8
Inadequacy of Device Shape and/or Size
7
7
Sticking
7
7
Metal Shedding Debris
7
7
Migration or Expulsion of Device
5
5
Tear, Rip or Hole in Device Packaging
5
5
Device Contaminated During Manufacture or Shipping
5
5
Material Fragmentation
5
5
Detachment of Device or Device Component
5
5
Crack
5
5
Device Damaged Prior to Use
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Mechanical Jam
4
4
Migration
4
4
Connection Problem
4
4
Component Missing
3
3
Device-Device Incompatibility
3
3
Failure to Disconnect
3
3
Difficult to Insert
3
3
Malposition of Device
3
3
Mechanics Altered
3
3
Component Falling
2
2
Material Erosion
2
2
Packaging Problem
2
2
Difficult To Position
2
2
Degraded
2
2
Use of Device Problem
2
2
Loss of or Failure to Bond
2
2
Disassembly
2
2
No Apparent Adverse Event
1
1
Difficult to Open or Close
1
1
Unraveled Material
1
1
Difficult or Delayed Positioning
1
1
Product Quality Problem
1
1
Device Contamination with Body Fluid
1
1
Improper or Incorrect Procedure or Method
1
1
Patient-Device Incompatibility
1
1
Nonstandard Device
1
1
Split
1
1
Material Too Soft/Flexible
1
1
Device Or Device Fragments Location Unknown
1
1
Positioning Problem
1
1
Disconnection
1
1
Device Disinfection Or Sterilization Issue
1
1
Device Contamination with Chemical or Other Material
1
1
Contamination of Device Ingredient or Reagent
1
1
Physical Resistance/Sticking
1
1
Peeled/Delaminated
1
1
Component or Accessory Incompatibility
1
1
Material Separation
1
1
Material Protrusion/Extrusion
1
1
Separation Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
129
129
Pain
51
51
No Code Available
44
44
No Information
42
42
Joint Dislocation
41
41
Unspecified Infection
36
36
No Consequences Or Impact To Patient
33
33
No Clinical Signs, Symptoms or Conditions
20
20
Failure of Implant
15
15
No Patient Involvement
15
15
Bone Fracture(s)
13
13
Toxicity
11
11
Fall
9
9
Ambulation Difficulties
8
8
Injury
8
8
Insufficient Information
6
6
Osteolysis
5
5
Swelling
5
5
Scar Tissue
4
4
Test Result
3
3
Reaction
3
3
Complaint, Ill-Defined
3
3
Sepsis
3
3
Loss of Range of Motion
3
3
Tissue Damage
3
3
Swelling/ Edema
3
3
Osteopenia/ Osteoporosis
3
3
Numbness
2
2
Metal Related Pathology
2
2
Blood Loss
2
2
Device Embedded In Tissue or Plaque
2
2
Unequal Limb Length
2
2
Malunion of Bone
2
2
Foreign Body In Patient
2
2
Inflammation
2
2
Arthritis
2
2
Hip Fracture
2
2
Fibrosis
2
2
Tissue Breakdown
1
1
Ossification
1
1
Sleep Dysfunction
1
1
Emotional Changes
1
1
Headache
1
1
Discomfort
1
1
Synovitis
1
1
Purulent Discharge
1
1
Atrial Fibrillation
1
1
Memory Loss/Impairment
1
1
High Blood Pressure/ Hypertension
1
1
Local Reaction
1
1
Bacterial Infection
1
1
Limited Mobility Of The Implanted Joint
1
1
Joint Swelling
1
1
Disability
1
1
Necrosis
1
1
Tinnitus
1
1
Hearing Loss
1
1
Hematoma
1
1
Hypersensitivity/Allergic reaction
1
1
Fluid Discharge
1
1
Hypovolemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Howmedica Osteonics Corp.
II
Feb-25-2016
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