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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
2019 741 741
2020 938 938
2021 2177 2177
2022 2096 2096
2023 2601 2601
2024 687 687

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4342 4342
Naturally Worn 1383 1383
Device-Device Incompatibility 1187 1187
Scratched Material 930 930
Crack 715 715
Detachment of Device or Device Component 601 601
Material Deformation 432 432
Material Twisted/Bent 398 398
Contamination /Decontamination Problem 301 301
Illegible Information 293 293
Fracture 267 267
Material Integrity Problem 189 189
Material Discolored 140 140
Mechanical Jam 134 134
Peeled/Delaminated 127 127
Component Missing 84 84
Adverse Event Without Identified Device or Use Problem 84 84
No Apparent Adverse Event 65 65
Unintended Movement 61 61
Entrapment of Device 59 59
Use of Device Problem 53 53
Corroded 44 44
Incorrect Measurement 42 42
Failure to Cut 40 40
Physical Resistance/Sticking 36 36
Appropriate Term/Code Not Available 23 23
Structural Problem 22 22
Dull, Blunt 18 18
Mechanical Problem 16 16
Loose or Intermittent Connection 15 15
Device Dislodged or Dislocated 15 15
Insufficient Information 13 13
Improper or Incorrect Procedure or Method 10 10
Compatibility Problem 9 9
Connection Problem 8 8
Difficult to Open or Close 8 8
Off-Label Use 8 8
Difficult to Remove 8 8
Material Fragmentation 7 7
Loss of Osseointegration 7 7
Loss of or Failure to Bond 6 6
Inadequacy of Device Shape and/or Size 6 6
Difficult or Delayed Separation 6 6
Migration 5 5
Device Slipped 5 5
Fitting Problem 4 4
Difficult to Insert 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Positioning Problem 4 4
Separation Problem 4 4
Material Split, Cut or Torn 3 3
Defective Device 3 3
Difficult to Advance 3 3
Degraded 3 3
Device Damaged Prior to Use 3 3
Tear, Rip or Hole in Device Packaging 2 2
Pitted 2 2
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Difficult to Maintain 1 1
Difficult to Open or Remove Packaging Material 1 1
Packaging Problem 1 1
Mechanics Altered 1 1
Activation, Positioning or Separation Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Device Damaged by Another Device 1 1
Failure to Align 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Flaked 1 1
Material Disintegration 1 1
Display Difficult to Read 1 1
Labelling, Instructions for Use or Training Problem 1 1
Delivered as Unsterile Product 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7267 7267
No Consequences Or Impact To Patient 1264 1264
Insufficient Information 388 388
No Code Available 125 125
No Patient Involvement 95 95
Not Applicable 65 65
No Known Impact Or Consequence To Patient 64 64
No Information 29 29
Foreign Body In Patient 26 26
Pain 23 23
Bone Fracture(s) 14 14
Unspecified Infection 11 11
Limb Fracture 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Injury 6 6
Joint Dislocation 5 5
Joint Laxity 4 4
Loss of Range of Motion 4 4
Cyst(s) 3 3
Metal Related Pathology 3 3
Unspecified Tissue Injury 3 3
Physical Asymmetry 3 3
Bruise/Contusion 2 2
Device Embedded In Tissue or Plaque 2 2
Osteolysis 2 2
Failure of Implant 2 2
Laceration(s) 2 2
Nerve Damage 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Synovitis 1 1
Discomfort 1 1
Pulmonary Embolism 1 1
Adhesion(s) 1 1
Death 1 1
Fall 1 1
Foreign Body Reaction 1 1
Ambulation Difficulties 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Patient Problem/Medical Problem 1 1
Inadequate Osseointegration 1 1
Unspecified Musculoskeletal problem 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Jul-20-2022
2 Materialise USA LLC II Aug-24-2022
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