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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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 2
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
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2073 2098
2024 806 806

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3874 3899
Device Dislodged or Dislocated 2348 2348
Insufficient Information 1191 1191
Appropriate Term/Code Not Available 996 996
Fracture 845 845
Osseointegration Problem 419 419
Naturally Worn 401 401
Break 340 340
Loosening of Implant Not Related to Bone-Ingrowth 263 263
Material Erosion 258 258
Loose or Intermittent Connection 243 243
Migration 193 193
Corroded 184 184
Unstable 159 159
Noise, Audible 145 145
Loss of Osseointegration 125 125
Patient Device Interaction Problem 115 115
Device Appears to Trigger Rejection 100 100
Detachment of Device or Device Component 90 90
Difficult to Insert 87 87
Tear, Rip or Hole in Device Packaging 80 80
Inadequacy of Device Shape and/or Size 73 73
Manufacturing, Packaging or Shipping Problem 72 72
Packaging Problem 68 68
Degraded 65 65
Malposition of Device 57 57
Failure to Osseointegrate 56 56
Unintended Movement 51 51
Use of Device Problem 49 49
Mechanical Problem 46 46
No Apparent Adverse Event 46 46
Biocompatibility 43 43
Material Integrity Problem 40 40
Device Contaminated During Manufacture or Shipping 39 39
Crack 39 39
Migration or Expulsion of Device 34 34
Difficult to Remove 33 33
Positioning Problem 32 32
Patient-Device Incompatibility 32 32
Scratched Material 28 28
Improper or Incorrect Procedure or Method 26 26
Positioning Failure 24 24
Fitting Problem 23 23
Loss of or Failure to Bond 20 20
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 14 14
Device Slipped 13 13
Microbial Contamination of Device 12 12
Device Damaged Prior to Use 11 11
Delivered as Unsterile Product 10 10
Physical Resistance/Sticking 10 10
Contamination /Decontamination Problem 10 10
Output Problem 9 9
Material Separation 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
Shipping Damage or Problem 3 3
Problem with Sterilization 3 3
Unexpected Therapeutic Results 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 2156 2156
Pain 2056 2056
Unspecified Infection 1881 1904
No Code Available 1456 1456
No Clinical Signs, Symptoms or Conditions 943 943
Insufficient Information 795 795
Failure of Implant 755 755
Inadequate Osseointegration 614 614
Bone Fracture(s) 555 557
No Information 521 521
Joint Laxity 387 387
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 373 373
Injury 372 372
Fall 317 317
Metal Related Pathology 296 296
No Known Impact Or Consequence To Patient 273 273
Reaction 244 244
Osteolysis 225 225
Foreign Body Reaction 215 215
Test Result 194 194
Ambulation Difficulties 192 192
Loss of Range of Motion 167 167
Limb Fracture 162 162
Tissue Damage 156 156
Inflammation 155 155
Joint Disorder 154 154
Discomfort 135 135
No Consequences Or Impact To Patient 111 111
Hip Fracture 100 100
Hematoma 94 94
Limited Mobility Of The Implanted Joint 91 91
Local Reaction 86 86
Implant Pain 85 85
Swelling/ Edema 85 85
Necrosis 80 80
Hypersensitivity/Allergic reaction 77 77
Ossification 72 72
Physical Asymmetry 71 71
Scar Tissue 69 69
Bacterial Infection 63 63
Unspecified Tissue Injury 60 60
Muscle/Tendon Damage 58 58
Unequal Limb Length 57 57
Fluid Discharge 57 57
Host-Tissue Reaction 57 57
Adhesion(s) 51 51
Synovitis 51 51
Swelling 47 47
Wound Dehiscence 45 45
Osteopenia/ Osteoporosis 44 44
Fatigue 43 43
Hemorrhage/Bleeding 35 35
Impaired Healing 33 33
No Patient Involvement 33 33
Thrombosis/Thrombus 33 33
Patient Problem/Medical Problem 29 29
Erythema 29 29
Fever 28 28
Pulmonary Embolism 28 28
Subluxation 27 27
Foreign Body In Patient 26 26
Blood Loss 24 24
Muscular Rigidity 24 24
Distress 24 24
Nerve Damage 22 22
Post Operative Wound Infection 21 21
Abscess 20 20
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 14 14
Numbness 13 13
Depression 12 12
Anemia 12 12
Infarction, Cerebral 12 12
Not Applicable 11 11
Low Blood Pressure/ Hypotension 10 10
Toxicity 10 10
Sepsis 10 10
Seroma 9 9
Muscle Weakness 9 9
Shaking/Tremors 9 9
Embolism/Embolus 9 9
Dizziness 8 8
Hearing Impairment 8 8
Memory Loss/Impairment 8 8
Erosion 8 8
Stroke/CVA 7 7
Headache 7 7
Sleep Dysfunction 7 7
Rash 7 7
Device Embedded In Tissue or Plaque 7 7
Cognitive Changes 7 7
Thromboembolism 7 7

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 Inc II May-24-2024
13 Smith & Nephew Orthopaedics AG II Aug-19-2020
14 Waldemar Link GmbH & Co. KG (Mfg Site) II Feb-29-2024
15 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-04-2023
16 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-14-2019
17 Zimmer Biomet, Inc. II Nov-07-2019
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