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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/ceramic/metal, cemented or uncemented
Product CodeMRA
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
14 14 12 28 17 9 18 26 16 11 17 13 18 33 19 13

MDR Year MDR Reports MDR Events
2014 280 280
2015 328 328
2016 367 367
2017 540 540
2018 696 696
2019 641 641
2020 371 371
2021 109 109
2022 89 89
2023 134 134
2024 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1472 1472
Insufficient Information 478 478
Fracture 440 440
Adverse Event Without Identified Device or Use Problem 307 307
Device Dislodged or Dislocated 200 200
Noise, Audible 149 149
Appropriate Term/Code Not Available 115 115
Loss of Osseointegration 79 79
Crack 73 73
Naturally Worn 68 68
Material Twisted/Bent 57 57
Malposition of Device 47 47
Material Deformation 44 44
Migration or Expulsion of Device 39 39
Loose or Intermittent Connection 38 38
Disassembly 34 34
Osseointegration Problem 29 29
Scratched Material 27 27
Loosening of Implant Not Related to Bone-Ingrowth 26 26
Corroded 25 25
Device-Device Incompatibility 23 23
Degraded 23 23
Unstable 22 22
Difficult to Remove 19 19
Mechanical Problem 16 16
Device Operates Differently Than Expected 16 16
Difficult to Insert 15 15
Loss of or Failure to Bond 14 14
Metal Shedding Debris 13 13
Inadequacy of Device Shape and/or Size 13 13
Connection Problem 12 12
Use of Device Problem 11 11
Biocompatibility 10 10
Patient Device Interaction Problem 10 10
Material Integrity Problem 10 10
Material Fragmentation 10 10
Device Slipped 9 9
Fitting Problem 9 9
Unintended Movement 8 8
Migration 8 8
Detachment of Device or Device Component 8 8
Positioning Problem 7 7
Failure To Adhere Or Bond 7 7
Physical Resistance/Sticking 6 6
Failure to Disconnect 6 6
Patient-Device Incompatibility 5 5
Failure to Osseointegrate 5 5
Mechanical Jam 5 5
Positioning Failure 5 5
Detachment Of Device Component 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1156 1156
No Information 628 628
Pain 503 503
No Code Available 378 378
Unspecified Infection 219 219
No Known Impact Or Consequence To Patient 203 203
Injury 194 194
Not Applicable 137 137
Bone Fracture(s) 114 114
Joint Dislocation 97 97
Insufficient Information 90 90
No Clinical Signs, Symptoms or Conditions 80 80
Failure of Implant 74 74
Discomfort 61 61
Device Embedded In Tissue or Plaque 53 53
Inadequate Osseointegration 51 51
Foreign Body Reaction 51 51
Metal Related Pathology 46 46
Ambulation Difficulties 43 43
Osteolysis 39 39
Inflammation 38 38
Reaction 36 36
Fall 36 36
Tissue Damage 35 35
Loss of Range of Motion 29 29
Limited Mobility Of The Implanted Joint 26 26
Host-Tissue Reaction 22 22
Swelling 21 21
Test Result 20 20
Joint Disorder 16 16
Hypersensitivity/Allergic reaction 15 15
Ossification 15 15
Foreign Body In Patient 14 14
Joint Laxity 12 12
Scar Tissue 12 12
Necrosis 12 12
Hematoma 12 12
Muscle/Tendon Damage 11 11
Hip Fracture 11 11
Edema 10 10
Synovitis 10 10
Swelling/ Edema 10 10
Blood Loss 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Weakness 9 9
Adhesion(s) 9 9
Cyst(s) 8 8
Toxicity 7 7
Myocardial Infarction 6 6
Unspecified Tissue Injury 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jun-02-2016
2 Smith & Nephew Inc II Apr-22-2011
3 Stryker Howmedica Osteonics Corp. II Aug-04-2009
4 Zimmer, Inc. II Feb-20-2014
5 Zimmer, Inc. II Feb-04-2013
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