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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Product CodeLZO
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
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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