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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device template
Product CodeHWT
Regulation Number 888.4800
Device Class 1

MDR Year MDR Reports MDR Events
2014 78 78
2015 93 93
2016 444 444
2017 651 651
2018 713 713
2019 741 741
2020 938 938
2021 2177 2177
2022 2096 2096
2023 2601 2601
2024 1059 1059

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5558 5558
Naturally Worn 1468 1468
Device-Device Incompatibility 1276 1276
Scratched Material 971 971
Crack 890 890
Detachment of Device or Device Component 636 636
Fracture 497 497
Material Deformation 462 462
Material Twisted/Bent 410 410
Contamination /Decontamination Problem 303 303
Illegible Information 294 294
Material Integrity Problem 199 199
Mechanical Jam 162 162
Component Missing 155 155
Peeled/Delaminated 150 150
Appropriate Term/Code Not Available 146 146
Material Discolored 144 144
Adverse Event Without Identified Device or Use Problem 111 111
Insufficient Information 94 94
No Apparent Adverse Event 72 72
Entrapment of Device 66 66
Unintended Movement 65 65
Use of Device Problem 55 55
Incorrect Measurement 50 50
Corroded 48 48
Failure to Cut 40 40
Physical Resistance/Sticking 40 40
Material Fragmentation 36 36
Disassembly 34 34
Loose or Intermittent Connection 32 32
Difficult to Remove 27 27
Device Dislodged or Dislocated 27 27
Device Operates Differently Than Expected 26 26
Structural Problem 23 23
Mechanical Problem 23 23
Bent 23 23
Device Contamination With Biological Material 22 22
Dull, Blunt 21 21
Connection Problem 18 18
Fitting Problem 17 17
Difficult to Insert 14 14
Compatibility Problem 12 12
Off-Label Use 10 10
Improper or Incorrect Procedure or Method 10 10
Residue After Decontamination 10 10
Device Slipped 10 10
Loss of Osseointegration 9 9
Difficult to Open or Close 9 9
Separation Failure 9 9
Inadequacy of Device Shape and/or Size 8 8
Detachment Of Device Component 8 8
Loss of or Failure to Bond 7 7
Malposition of Device 7 7
Device Markings/Labelling Problem 7 7
Device Operational Issue 6 6
Positioning Problem 6 6
Separation Problem 6 6
Difficult or Delayed Separation 6 6
Migration 5 5
Defective Device 5 5
Device Issue 4 4
Unstable 4 4
Device Damaged Prior to Use 4 4
Device Reprocessing Problem 4 4
Component Falling 4 4
Failure To Adhere Or Bond 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Distortion 3 3
Difficult to Advance 3 3
Material Split, Cut or Torn 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Degraded 3 3
Migration or Expulsion of Device 3 3
Sticking 3 3
Device Or Device Fragments Location Unknown 3 3
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Delivered as Unsterile Product 2 2
Defective Component 2 2
Tear, Rip or Hole in Device Packaging 2 2
Pitted 2 2
Material Disintegration 2 2
Incomplete or Inadequate Connection 2 2
Device Damaged by Another Device 2 2
Device Contaminated During Manufacture or Shipping 2 2
Torn Material 2 2
Patient Device Interaction Problem 2 2
Device Handling Problem 2 2
Noise, Audible 1 1
Misassembly by Users 1 1
Device Difficult to Maintain 1 1
Protective Measures Problem 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Mechanics Altered 1 1
Difficult to Open or Remove Packaging Material 1 1
Inaccurate Information 1 1
Display Difficult to Read 1 1
Device Expiration Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7496 7496
No Consequences Or Impact To Patient 1901 1901
No Information 623 623
No Known Impact Or Consequence To Patient 545 545
Insufficient Information 537 537
No Code Available 182 182
No Patient Involvement 168 168
Not Applicable 86 86
Pain 55 55
Foreign Body In Patient 47 47
Reaction 35 35
Unspecified Infection 31 31
Device Embedded In Tissue or Plaque 28 28
Bone Fracture(s) 27 27
Sedation 21 21
Injury 9 9
Joint Dislocation 8 8
Limb Fracture 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Loss of Range of Motion 6 6
Tissue Damage 4 4
Osteolysis 4 4
Impaired Healing 4 4
Joint Laxity 4 4
Metal Related Pathology 3 3
Unspecified Tissue Injury 3 3
Physical Asymmetry 3 3
Ambulation Difficulties 3 3
Paresis 3 3
Discomfort 3 3
Complaint, Ill-Defined 3 3
Cyst(s) 3 3
Failure of Implant 3 3
Muscle Weakness 3 3
Inflammation 2 2
Laceration(s) 2 2
Bruise/Contusion 2 2
Wound Dehiscence 2 2
Neck Pain 2 2
Swelling/ Edema 2 2
Unspecified Musculoskeletal problem 1 1
Blood Loss 1 1
Inadequate Osseointegration 1 1
Limited Mobility Of The Implanted Joint 1 1
Patient Problem/Medical Problem 1 1
Joint Swelling 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Swelling 1 1
Synovitis 1 1
Paralysis 1 1
Pulmonary Embolism 1 1
Adhesion(s) 1 1
Hematoma 1 1
Death 1 1
Fall 1 1
Fever 1 1
Foreign Body Reaction 1 1
Infiltration into Tissue 1 1
Nerve Damage 1 1
Occlusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Feb-12-2018
2 Aesculap Implant Systems LLC II Jul-31-2012
3 Biomet Microfixation, LLC II May-12-2017
4 Biomet, Inc. II Jul-14-2015
5 Biomet, Inc. II Oct-16-2014
6 DePuy Orthopaedics, Inc. II Jul-20-2022
7 DePuy Orthopaedics, Inc. II Apr-09-2014
8 DePuy Orthopaedics, Inc. II Jun-07-2013
9 Encore Medical, Lp II Jul-27-2015
10 Integra LifeSciences Corp. II Apr-20-2018
11 Materialise USA LLC II Aug-24-2022
12 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Aug-26-2013
13 Zimmer Inc. II Dec-14-2010
14 Zimmer Inc. II Jan-23-2009
15 Zimmer, Inc. II Dec-06-2013
16 Zimmer, Inc. II Nov-19-2012
17 Zimmer, Inc. II Sep-28-2012
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