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TPLC
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Device
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Product Code
LZO
Regulation Number
888.3353
Device Class
2
Premarket Reviews
Manufacturer
Decision
B-ONE ORTHO CORP.
SUBSTANTIALLY EQUIVALENT
2
BIOMET ORTHOPEDICS
SUBSTANTIALLY EQUIVALENT
1
BIOMET UK LTD.
SUBSTANTIALLY EQUIVALENT
2
CORENTEC CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
CORIN LTD.
SUBSTANTIALLY EQUIVALENT
1
CORIN USA
SUBSTANTIALLY EQUIVALENT
2
CORIN USA LIMITED
SUBSTANTIALLY EQUIVALENT
3
DEPUY (IRELAND)
SUBSTANTIALLY EQUIVALENT
1
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
5
DEPUY ORTHOPAEDICS INC.
SUBSTANTIALLY EQUIVALENT
2
DEPUY ORTHOPAEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
EXACTECH, INC
SUBSTANTIALLY EQUIVALENT
1
EXACTECH, INC.
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST GMBH
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST, GMBH
SUBSTANTIALLY EQUIVALENT
3
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
2
MAXX ORTHOPEDICS INC.
SUBSTANTIALLY EQUIVALENT
1
MAXX ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL S .A.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL S.A.
SUBSTANTIALLY EQUIVALENT
2
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
10
MEDACTA INTERNATIONAL, SA
SUBSTANTIALLY EQUIVALENT
1
MERIL HEALTHCARE PVT. LTD.
SUBSTANTIALLY EQUIVALENT
1
MICROPORT ORTHOPEDICS INC.
SUBSTANTIALLY EQUIVALENT
2
ORCHARD MEDICAL DEVELOPMENT
SUBSTANTIALLY EQUIVALENT
1
SERF
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
5
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
2
TOTAL JOINT ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
TOTAL JOINT OTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
2
UNITED ORTHOPEDIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
WALDEMAR LINK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
6
WALDEMAR LINK GMBH & CO.KG
SUBSTANTIALLY EQUIVALENT
1
XERXES ARTHOPEDIX LLC
SUBSTANTIALLY EQUIVALENT
1
ZIMMER GMBH
SUBSTANTIALLY EQUIVALENT
5
ZIMMER, INC
SUBSTANTIALLY EQUIVALENT
1
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
3074
3074
2020
1956
1956
2021
2200
2200
2022
1985
1985
2023
2068
2093
2024
378
378
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3710
3735
Device Dislodged or Dislocated
2305
2305
Insufficient Information
1174
1174
Appropriate Term/Code Not Available
991
991
Fracture
818
818
Osseointegration Problem
382
382
Break
332
332
Naturally Worn
301
301
Loosening of Implant Not Related to Bone-Ingrowth
258
258
Material Erosion
256
256
Loose or Intermittent Connection
243
243
Corroded
183
183
Migration
182
182
Unstable
156
156
Noise, Audible
142
142
Loss of Osseointegration
115
115
Patient Device Interaction Problem
114
114
Difficult to Insert
86
86
Detachment of Device or Device Component
85
85
Device Appears to Trigger Rejection
83
83
Tear, Rip or Hole in Device Packaging
77
77
Inadequacy of Device Shape and/or Size
72
72
Manufacturing, Packaging or Shipping Problem
69
69
Packaging Problem
67
67
Degraded
62
62
Malposition of Device
56
56
Failure to Osseointegrate
51
51
Unintended Movement
50
50
Use of Device Problem
46
46
Mechanical Problem
46
46
No Apparent Adverse Event
44
44
Biocompatibility
42
42
Material Integrity Problem
40
40
Crack
39
39
Device Contaminated During Manufacture or Shipping
37
37
Migration or Expulsion of Device
34
34
Positioning Problem
32
32
Patient-Device Incompatibility
32
32
Difficult to Remove
31
31
Scratched Material
27
27
Improper or Incorrect Procedure or Method
24
24
Fitting Problem
23
23
Positioning Failure
22
22
Loss of or Failure to Bond
19
19
Mechanical Jam
19
19
Inaccurate Information
19
19
Material Fragmentation
18
18
Device Markings/Labelling Problem
17
17
Device-Device Incompatibility
17
17
Material Deformation
16
16
Off-Label Use
16
16
Material Disintegration
15
15
Separation Failure
14
14
Activation, Positioning or Separation Problem
14
14
Wrong Label
13
13
Device Slipped
13
13
Microbial Contamination of Device
12
12
Device Damaged Prior to Use
10
10
Physical Resistance/Sticking
10
10
Contamination /Decontamination Problem
10
10
Output Problem
9
9
Material Separation
9
9
Delivered as Unsterile Product
9
9
Labelling, Instructions for Use or Training Problem
8
8
Deformation Due to Compressive Stress
8
8
Device Damaged by Another Device
8
8
Difficult to Open or Remove Packaging Material
7
7
Nonstandard Device
7
7
Connection Problem
6
6
Failure to Disconnect
6
6
Unsealed Device Packaging
5
5
Component Incompatible
5
5
Expiration Date Error
5
5
Failure to Align
5
5
Defective Device
4
4
Defective Component
4
4
Difficult or Delayed Positioning
4
4
Material Discolored
4
4
Component or Accessory Incompatibility
4
4
Human-Device Interface Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Separation Problem
4
4
Difficult or Delayed Separation
4
4
Compatibility Problem
3
3
Particulates
3
3
Peeled/Delaminated
3
3
Component Missing
3
3
Incomplete or Missing Packaging
3
3
No Device Output
3
3
Problem with Sterilization
3
3
Unexpected Therapeutic Results
2
2
Shipping Damage or Problem
2
2
Material Puncture/Hole
2
2
Entrapment of Device
2
2
Unintended System Motion
2
2
Flaked
2
2
Collapse
2
2
Expulsion
2
2
Material Protrusion/Extrusion
2
2
Material Twisted/Bent
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Joint Dislocation
2097
2097
Pain
1983
1983
Unspecified Infection
1828
1851
No Code Available
1456
1456
No Clinical Signs, Symptoms or Conditions
899
899
Insufficient Information
740
740
Failure of Implant
650
650
Inadequate Osseointegration
592
592
Bone Fracture(s)
524
526
No Information
521
521
Injury
372
372
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
371
371
Joint Laxity
362
362
Fall
302
302
Metal Related Pathology
285
285
No Known Impact Or Consequence To Patient
273
273
Reaction
244
244
Osteolysis
211
211
Foreign Body Reaction
210
210
Test Result
194
194
Ambulation Difficulties
183
183
Loss of Range of Motion
156
156
Tissue Damage
156
156
Joint Disorder
154
154
Inflammation
152
152
Limb Fracture
143
143
Discomfort
132
132
No Consequences Or Impact To Patient
111
111
Hip Fracture
99
99
Limited Mobility Of The Implanted Joint
91
91
Hematoma
88
88
Local Reaction
86
86
Implant Pain
83
83
Necrosis
80
80
Swelling/ Edema
79
79
Hypersensitivity/Allergic reaction
76
76
Ossification
70
70
Scar Tissue
67
67
Physical Asymmetry
63
63
Unspecified Tissue Injury
59
59
Bacterial Infection
59
59
Host-Tissue Reaction
57
57
Fluid Discharge
55
55
Muscle/Tendon Damage
51
51
Unequal Limb Length
50
50
Adhesion(s)
50
50
Synovitis
49
49
Swelling
47
47
Osteopenia/ Osteoporosis
43
43
Wound Dehiscence
41
41
Fatigue
39
39
No Patient Involvement
33
33
Thrombosis/Thrombus
31
31
Hemorrhage/Bleeding
31
31
Impaired Healing
31
31
Patient Problem/Medical Problem
29
29
Erythema
28
28
Fever
28
28
Pulmonary Embolism
26
26
Subluxation
26
26
Foreign Body In Patient
25
25
Blood Loss
24
24
Muscular Rigidity
24
24
Distress
24
24
Post Operative Wound Infection
20
20
Nerve Damage
20
20
Abscess
19
19
Edema
19
19
Arthralgia
19
19
Deformity/ Disfigurement
18
18
Weakness
17
17
Cyst(s)
17
17
Death
15
15
Cardiac Arrest
15
15
Anxiety
15
15
Myocardial Infarction
14
14
Unspecified Musculoskeletal problem
13
13
Anemia
12
12
Infarction, Cerebral
12
12
Depression
12
12
Not Applicable
11
11
Toxicity
10
10
Numbness
10
10
Shaking/Tremors
9
9
Sepsis
9
9
Embolism/Embolus
9
9
Seroma
8
8
Dizziness
8
8
Erosion
8
8
Memory Loss/Impairment
8
8
Hearing Impairment
8
8
Low Blood Pressure/ Hypotension
8
8
Stroke/CVA
7
7
Sleep Dysfunction
7
7
Rash
7
7
Headache
7
7
Device Embedded In Tissue or Plaque
7
7
Cognitive Changes
7
7
Thromboembolism
6
6
Balance Problems
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Dec-18-2023
2
Biomet, Inc.
II
May-28-2020
3
Corin Ltd
II
Dec-19-2022
4
Encore Medical, LP
II
Sep-19-2023
5
Exactech, Inc.
II
Sep-09-2022
6
Exactech, Inc.
II
Aug-12-2021
7
Exactech, Inc.
II
Jul-22-2021
8
Howmedica Osteonics Corp.
II
Mar-31-2022
9
IMPLANTCAST GMBH
II
Jul-09-2021
10
OMNIlife science Inc.
II
Jan-26-2021
11
OMNIlife science Inc.
II
Sep-05-2019
12
Smith & Nephew Orthopaedics AG
II
Aug-19-2020
13
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Feb-29-2024
14
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Aug-04-2023
15
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Jan-14-2019
16
Zimmer Biomet, Inc.
II
Nov-07-2019
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