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TPLC
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Device
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Product Code
MEH
Regulation Number
888.3353
Device Class
2
Premarket Reviews
Manufacturer
Decision
AESCULAP IMPLANT SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
AESCULAP IMPLANT SYSTEMS, LLC
SUBSTANTIALLY EQUIVALENT
1
CONFORMIS INC
SUBSTANTIALLY EQUIVALENT
1
CONFORMIS INC.
SUBSTANTIALLY EQUIVALENT
1
CORIN U.S.A.
SUBSTANTIALLY EQUIVALENT
1
CORIN USA
SUBSTANTIALLY EQUIVALENT
1
CORIN USA LIMITED
SUBSTANTIALLY EQUIVALENT
2
DEPUY (IRELAND)
SUBSTANTIALLY EQUIVALENT
1
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
2
DEPUY ORTHOPAEDICS, INC.
SUBSTANTIALLY EQUIVALENT
2
EXACTECH INC
SUBSTANTIALLY EQUIVALENT
2
EXACTECH, INC.
SUBSTANTIALLY EQUIVALENT
1
GLOBAL MANUFACTURING TECHNOLOGY
SUBSTANTIALLY EQUIVALENT
2
HOWMEDICA OSTEONICS CORP
SUBSTANTIALLY EQUIVALENT
4
HOWMEDICA OSTEONICS CORP.
SUBSTANTIALLY EQUIVALENT
2
IMPLANTCAST GMBH
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST, GMBH
SUBSTANTIALLY EQUIVALENT
1
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
3
MEDACTA INTERNATIONAL, SA
SUBSTANTIALLY EQUIVALENT
2
ORTHO DEVELOPMENT CORP.
SUBSTANTIALLY EQUIVALENT
1
ORTHO DEVELOPMENT CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
6
SMITH & NEPHEW INC.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
5
STRYKER
SUBSTANTIALLY EQUIVALENT
1
1. K103479
NOVEL TAPERED HIP STEM
STRYKER CORP
SUBSTANTIALLY EQUIVALENT
1
1. K103479
NOVEL TAPERED HIP STEM
STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
UNITED ORTHOPEDIC CORP.
SUBSTANTIALLY EQUIVALENT
1
WALDEMAR LINK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1192
1192
2015
487
487
2016
347
347
2017
382
382
2018
337
337
2019
341
341
2020
337
337
2021
372
372
2022
316
316
2023
334
334
2024
138
138
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
1127
1127
Adverse Event Without Identified Device or Use Problem
733
733
Device Dislodged or Dislocated
480
480
Device-Device Incompatibility
314
314
Appropriate Term/Code Not Available
306
306
Break
258
258
Fracture
245
245
Loose or Intermittent Connection
193
193
Nonstandard Device
168
168
Device Slipped
122
122
Corroded
112
112
Device Operates Differently Than Expected
109
109
Naturally Worn
85
85
Osseointegration Problem
82
82
Degraded
77
77
Metal Shedding Debris
74
74
Unstable
69
69
Material Integrity Problem
62
62
Malposition of Device
58
58
Mechanical Problem
57
57
Loss of Osseointegration
57
57
Detachment of Device or Device Component
56
56
Noise, Audible
51
51
Migration or Expulsion of Device
45
45
Material Erosion
45
45
Migration
38
38
Loosening of Implant Not Related to Bone-Ingrowth
37
37
Material Deformation
37
37
Inadequacy of Device Shape and/or Size
35
35
Positioning Problem
31
31
Patient-Device Incompatibility
27
27
Detachment Of Device Component
26
26
Material Separation
24
24
Device Contaminated During Manufacture or Shipping
24
24
Device Contamination with Chemical or Other Material
23
23
Device Appears to Trigger Rejection
21
21
Tear, Rip or Hole in Device Packaging
17
17
Unintended Movement
16
16
Difficult to Remove
14
14
Contamination
13
13
Sticking
12
12
Failure To Adhere Or Bond
11
11
Packaging Problem
11
11
Scratched Material
10
10
Device Packaging Compromised
10
10
Component Missing
10
10
Fitting Problem
9
9
Microbial Contamination of Device
9
9
Use of Device Problem
9
9
Compatibility Problem
9
9
No Apparent Adverse Event
8
8
Material Protrusion/Extrusion
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Failure to Cut
7
7
Defective Device
7
7
Off-Label Use
7
7
Material Discolored
7
7
Crack
7
7
Material Fragmentation
7
7
Difficult to Insert
6
6
Product Quality Problem
6
6
Improper or Incorrect Procedure or Method
6
6
Contamination of Device Ingredient or Reagent
6
6
Device Markings/Labelling Problem
6
6
Inaccurate Information
6
6
Patient Device Interaction Problem
5
5
Connection Problem
5
5
Residue After Decontamination
5
5
Disassembly
5
5
Entrapment of Device
5
5
Disconnection
4
4
Difficult To Position
4
4
Separation Failure
4
4
Failure to Align
4
4
Device Disinfection Or Sterilization Issue
4
4
Mechanical Jam
4
4
Device Damaged by Another Device
3
3
Device Damaged Prior to Use
3
3
Component Falling
3
3
Accessory Incompatible
2
2
Loss of or Failure to Bond
2
2
Positioning Failure
2
2
Inadequate Instructions for Healthcare Professional
2
2
Leak/Splash
2
2
Delivered as Unsterile Product
2
2
Unintended Collision
2
2
Defective Component
2
2
Device Inoperable
2
2
Failure to Osseointegrate
2
2
Incomplete or Missing Packaging
2
2
Loss of Power
2
2
Material Too Rigid or Stiff
2
2
Incorrect Device Or Component Shipped
2
2
Human-Device Interface Problem
2
2
Deformation Due to Compressive Stress
2
2
Calibration Problem
2
2
Device Contamination With Biological Material
2
2
Mechanics Altered
2
2
Material Twisted/Bent
1
1
Operating System Becomes Nonfunctional
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
1118
1118
Injury
793
793
Unspecified Infection
612
612
No Code Available
540
540
Joint Dislocation
307
307
Inflammation
271
271
Reaction
259
259
No Known Impact Or Consequence To Patient
232
232
No Information
229
229
Bone Fracture(s)
189
189
Fall
157
157
Ambulation Difficulties
151
151
Metal Related Pathology
147
147
Toxicity
134
134
Foreign Body Reaction
134
134
Insufficient Information
133
133
No Clinical Signs, Symptoms or Conditions
130
130
Inadequate Osseointegration
124
124
Failure of Implant
114
114
Limb Fracture
101
101
Discomfort
90
90
No Consequences Or Impact To Patient
89
89
Swelling
83
83
Osteolysis
79
79
Test Result
58
58
Joint Disorder
48
48
No Patient Involvement
46
46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
36
36
Tissue Damage
32
32
Joint Laxity
31
31
Bacterial Infection
29
29
Limited Mobility Of The Implanted Joint
27
27
Loss of Range of Motion
26
26
Hip Fracture
25
25
Necrosis
24
24
Local Reaction
24
24
Hematoma
24
24
Fluid Discharge
21
21
Complaint, Ill-Defined
20
20
Numbness
15
15
Cyst(s)
15
15
Host-Tissue Reaction
15
15
Edema
14
14
Device Embedded In Tissue or Plaque
14
14
Weakness
13
13
Implant Pain
13
13
Muscle/Tendon Damage
12
12
Ossification
12
12
Staphylococcus Aureus
12
12
Joint Swelling
11
11
Physical Asymmetry
11
11
Swelling/ Edema
11
11
Muscular Rigidity
10
10
Fatigue
9
9
Disability
9
9
Burning Sensation
9
9
Unequal Limb Length
9
9
Chemical Exposure
8
8
Hypersensitivity/Allergic reaction
8
8
Death
8
8
Osteopenia/ Osteoporosis
7
7
Foreign Body In Patient
7
7
Arthralgia
7
7
Impaired Healing
7
7
Deformity/ Disfigurement
6
6
Patient Problem/Medical Problem
6
6
Wound Dehiscence
6
6
Arthritis
6
6
Hemorrhage/Bleeding
6
6
Scar Tissue
6
6
Unspecified Tissue Injury
6
6
Synovitis
5
5
Nerve Damage
5
5
Granuloma
5
5
Purulent Discharge
5
5
Abscess
5
5
Erosion
5
5
Heart Failure/Congestive Heart Failure
5
5
Inadequate Pain Relief
5
5
Depression
4
4
Pneumonia
4
4
Sleep Dysfunction
4
4
Post Operative Wound Infection
4
4
Erythema
4
4
Muscle Spasm(s)
4
4
Muscle Weakness
4
4
Seroma
4
4
Scarring
3
3
Sepsis
3
3
Itching Sensation
3
3
Laceration(s)
3
3
Paralysis
3
3
Calcium Deposits/Calcification
3
3
Cardiomyopathy
3
3
Aspiration/Inhalation
3
3
Weight Changes
3
3
Confusion/ Disorientation
3
3
Not Applicable
3
3
Peroneal Nerve Palsy
3
3
Non-union Bone Fracture
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Dec-17-2020
2
Corin Ltd
II
Sep-30-2021
3
Corin Ltd
II
Jun-11-2021
4
Corin Ltd
II
Mar-22-2021
5
Depuy Orthopaedics Inc.
II
Nov-21-2016
6
Exactech, Inc.
II
Sep-09-2022
7
Exactech, Inc.
II
Jan-18-2018
8
Exactech, Inc.
II
Nov-02-2015
9
Medacta Usa Inc
II
Feb-23-2013
10
Medacta Usa Inc
II
Feb-07-2013
11
Medacta Usa Inc
II
Jun-30-2011
12
Signature Orthopaedics Europe Ltd
II
Mar-25-2020
13
Signature Orthopedics Pty Limited
II
May-28-2021
14
Signature Orthopedics Pty Limited
II
Mar-06-2018
15
Smith & Nephew Inc
II
Sep-20-2012
16
Smith & Nephew, Inc.
II
Jan-04-2017
17
Smith & Nephew, Inc.
II
Jul-28-2016
18
Stryker Howmedica Osteonics Corp.
II
Feb-03-2015
19
Stryker Howmedica Osteonics Corp.
II
Apr-02-2014
20
Stryker Howmedica Osteonics Corp.
II
Jan-08-2013
21
Stryker Howmedica Osteonics Corp.
II
Jul-26-2012
22
Stryker Howmedica Osteonics Corp.
II
May-29-2012
23
Stryker Howmedica Osteonics Corp.
II
Jan-30-2012
24
Stryker Howmedica Osteonics Corp.
II
Oct-20-2011
25
Stryker Howmedica Osteonics Corp.
II
Feb-07-2011
26
Stryker Howmedica Osteonics Corp.
II
Apr-19-2010
27
Stryker Howmedica Osteonics Corp.
II
Dec-22-2009
28
Stryker Howmedica Osteonics Corp.
III
Sep-14-2009
29
Stryker Howmedica Osteonics Corp.
II
Aug-13-2009
30
Stryker Howmedica Osteonics Corp.
II
Jul-22-2009
31
Stryker Howmedica Osteonics Corp.
II
Jan-26-2009
32
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Jan-11-2019
33
Zimmer Gmbh
II
Feb-20-2015
34
Zimmer, Inc.
II
Feb-04-2013
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