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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
AESCULAP IMPLANTS SYSTEMS, LLC
SUBSTANTIALLY EQUIVALENT
1
B-ONE ORTHO CORP.
SUBSTANTIALLY EQUIVALENT
3
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
3
CORIN USA LIMITED
SUBSTANTIALLY EQUIVALENT
3
DEPUY (IRELAND)
SUBSTANTIALLY EQUIVALENT
1
DEPUY FRANCE S.A.S.
SUBSTANTIALLY EQUIVALENT
1
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
5
DEPUY ORTHOPAEDICS INC.
SUBSTANTIALLY EQUIVALENT
2
DEPUY ORTHOPAEDICS, INC.
SUBSTANTIALLY EQUIVALENT
2
EXACTECH, INC
SUBSTANTIALLY EQUIVALENT
1
EXACTECH, INC.
SUBSTANTIALLY EQUIVALENT
3
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST GMBH
SUBSTANTIALLY EQUIVALENT
2
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
13
MEDACTA INTERNATIONAL, SA
SUBSTANTIALLY EQUIVALENT
1
MERIL HEALTHCARE PVT. LTD.
SUBSTANTIALLY EQUIVALENT
1
MICROPORT ORTHOPEDICS INC.
SUBSTANTIALLY EQUIVALENT
4
MICROPORT ORTHOPEDICS INC. (MPO)
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
2
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
3
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2018
3127
3127
2019
3074
3074
2020
1955
1955
2021
2197
2197
2022
1982
1982
2023
1704
1729
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3846
3871
Device Dislodged or Dislocated
2747
2747
Insufficient Information
2309
2309
Appropriate Term/Code Not Available
1219
1219
Fracture
905
905
Break
365
365
Osseointegration Problem
340
340
Loose or Intermittent Connection
338
338
Naturally Worn
337
337
Material Erosion
293
293
Loosening of Implant Not Related to Bone-Ingrowth
251
251
Corroded
225
225
Unstable
215
215
Migration
180
180
Noise, Audible
160
160
Loss of Osseointegration
126
126
Patient Device Interaction Problem
107
107
Difficult to Insert
100
100
Migration or Expulsion of Device
93
93
Inadequacy of Device Shape and/or Size
87
87
Detachment of Device or Device Component
85
85
Device Appears to Trigger Rejection
73
73
Packaging Problem
72
72
Degraded
69
69
Malposition of Device
68
68
Tear, Rip or Hole in Device Packaging
63
63
Unintended Movement
57
57
Manufacturing, Packaging or Shipping Problem
55
55
No Apparent Adverse Event
53
53
Mechanical Problem
53
53
Failure to Osseointegrate
47
47
Use of Device Problem
45
45
Material Integrity Problem
44
44
Crack
42
42
Device Slipped
41
41
Patient-Device Incompatibility
41
41
Positioning Problem
39
39
Biocompatibility
38
38
Device Contaminated During Manufacture or Shipping
36
36
Difficult to Remove
36
36
Material Deformation
30
30
Loss of or Failure to Bond
29
29
Scratched Material
28
28
Improper or Incorrect Procedure or Method
26
26
Fitting Problem
25
25
Material Disintegration
25
25
Material Fragmentation
24
24
Mechanical Jam
23
23
Positioning Failure
22
22
Device-Device Incompatibility
20
20
Device Markings/Labelling Problem
19
19
Inaccurate Information
19
19
Metal Shedding Debris
19
19
Microbial Contamination of Device
19
19
Off-Label Use
17
17
Separation Failure
16
16
Device Damaged Prior to Use
15
15
Activation, Positioning or Separation Problem
14
14
Device Contamination with Chemical or Other Material
14
14
Wrong Label
13
13
Material Separation
13
13
Problem with Sterilization
13
13
Disassembly
13
13
Device Damaged by Another Device
11
11
Contamination /Decontamination Problem
11
11
Defective Device
10
10
Physical Resistance/Sticking
10
10
Output Problem
10
10
Difficult to Open or Remove Packaging Material
9
9
Deformation Due to Compressive Stress
8
8
Separation Problem
8
8
Labelling, Instructions for Use or Training Problem
8
8
Nonstandard Device
8
8
Delivered as Unsterile Product
8
8
Unsealed Device Packaging
8
8
Material Discolored
7
7
Device Operates Differently Than Expected
7
7
Connection Problem
6
6
Contamination
6
6
Component Incompatible
5
5
Misassembled
5
5
Difficult To Position
5
5
Defective Component
5
5
Component Missing
5
5
Incomplete or Missing Packaging
5
5
Failure to Align
5
5
Failure to Disconnect
5
5
Human-Device Interface Problem
5
5
Expiration Date Error
4
4
Component or Accessory Incompatibility
4
4
Difficult or Delayed Separation
4
4
Therapeutic or Diagnostic Output Failure
4
4
Particulates
4
4
Difficult or Delayed Positioning
4
4
Disconnection
3
3
Entrapment of Device
3
3
No Device Output
3
3
Peeled/Delaminated
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Compatibility Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
2578
2578
Joint Dislocation
2478
2478
Unspecified Infection
2108
2131
No Code Available
1806
1806
No Information
811
811
No Clinical Signs, Symptoms or Conditions
804
804
Injury
744
744
Insufficient Information
645
645
Failure of Implant
636
636
Bone Fracture(s)
635
637
Inadequate Osseointegration
576
576
Reaction
522
522
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
362
362
Joint Laxity
338
338
No Known Impact Or Consequence To Patient
335
335
Inflammation
313
313
Fall
305
305
Not Applicable
267
267
Test Result
265
265
Joint Disorder
263
263
Metal Related Pathology
263
263
Tissue Damage
257
257
Osteolysis
244
244
Ambulation Difficulties
230
230
Foreign Body Reaction
215
215
Discomfort
211
211
No Consequences Or Impact To Patient
186
186
Loss of Range of Motion
186
186
Hip Fracture
157
157
Limited Mobility Of The Implanted Joint
138
138
Limb Fracture
137
137
Hematoma
123
123
Necrosis
111
111
Local Reaction
110
110
Blood Loss
91
91
Bacterial Infection
86
86
Host-Tissue Reaction
84
84
Swelling
83
83
Ossification
79
79
Hypersensitivity/Allergic reaction
79
79
Impaired Healing
77
77
Implant Pain
71
71
Swelling/ Edema
70
70
Scar Tissue
67
67
Synovitis
63
63
Fluid Discharge
61
61
Physical Asymmetry
60
60
Unspecified Tissue Injury
57
57
Wound Dehiscence
56
56
Adhesion(s)
53
53
Fatigue
48
48
Muscle/Tendon Damage
48
48
Unequal Limb Length
45
45
Distress
43
43
Osteopenia/ Osteoporosis
42
42
No Patient Involvement
40
40
Weakness
36
36
Thrombosis
35
35
Pulmonary Embolism
34
34
Patient Problem/Medical Problem
32
32
Fever
31
31
Hemorrhage/Bleeding
30
30
Edema
29
29
Foreign Body In Patient
29
29
Erythema
27
27
Deformity/ Disfigurement
27
27
Post Operative Wound Infection
26
26
Thrombosis/Thrombus
24
24
Muscular Rigidity
24
24
Cyst(s)
23
23
Cardiac Arrest
23
23
Abscess
22
22
Subluxation
22
22
Anxiety
21
21
Infarction, Cerebral
20
20
Death
20
20
Arthralgia
19
19
Nerve Damage
19
19
Cellulitis
18
18
Anemia
17
17
Depression
17
17
Myocardial Infarction
15
15
Urinary Retention
12
12
Toxicity
12
12
Numbness
12
12
Unspecified Musculoskeletal problem
12
12
Urinary Tract Infection
11
11
Granuloma
11
11
Hearing Impairment
10
10
Seroma
10
10
Device Embedded In Tissue or Plaque
10
10
Embolism/Embolus
9
9
Shaking/Tremors
9
9
Dizziness
9
9
Erosion
9
9
Low Blood Pressure/ Hypotension
8
8
Pneumonia
8
8
Sleep Dysfunction
8
8
Tinnitus
7
7
Non-union Bone Fracture
7
7
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
May-28-2020
2
Corin Ltd
II
Dec-19-2022
3
Encore Medical, LP
II
Sep-19-2023
4
Exactech, Inc.
II
Sep-09-2022
5
Exactech, Inc.
II
Aug-12-2021
6
Exactech, Inc.
II
Jul-22-2021
7
Howmedica Osteonics Corp.
II
Mar-31-2022
8
IMPLANTCAST GMBH
II
Jul-09-2021
9
IMPLANTCAST GMBH
II
Jul-20-2018
10
Medacta Usa Inc
II
Oct-19-2018
11
OMNIlife science Inc.
II
Jan-26-2021
12
OMNIlife science Inc.
II
Sep-05-2019
13
Smith & Nephew Orthopaedics AG
II
Aug-19-2020
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
17
Zimmer Biomet, Inc.
II
Apr-16-2018
18
Zimmer Biomet, Inc.
II
Mar-14-2018
19
Zimmer GmbH
II
Dec-20-2018
20
Zimmer GmbH
II
Apr-26-2018
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