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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 1286 1286

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4631 4631
Naturally Worn 1448 1448
Device-Device Incompatibility 1267 1267
Scratched Material 985 985
Crack 777 777
Detachment of Device or Device Component 638 638
Material Deformation 452 452
Material Twisted/Bent 401 401
Contamination /Decontamination Problem 307 307
Illegible Information 297 297
Fracture 282 282
Material Integrity Problem 200 200
Mechanical Jam 146 146
Material Discolored 140 140
Peeled/Delaminated 135 135
No Apparent Adverse Event 132 132
Adverse Event Without Identified Device or Use Problem 85 85
Component Missing 84 84
Entrapment of Device 64 64
Unintended Movement 64 64
Corroded 56 56
Use of Device Problem 53 53
Incorrect Measurement 43 43
Failure to Cut 40 40
Physical Resistance/Sticking 36 36
Appropriate Term/Code Not Available 26 26
Structural Problem 22 22
Insufficient Information 18 18
Dull, Blunt 18 18
Mechanical Problem 16 16
Device Dislodged or Dislocated 16 16
Loose or Intermittent Connection 15 15
Improper or Incorrect Procedure or Method 12 12
Compatibility Problem 12 12
Loss of Osseointegration 10 10
Off-Label Use 9 9
Material Fragmentation 9 9
Difficult to Remove 8 8
Connection Problem 8 8
Difficult to Open or Close 8 8
Inadequacy of Device Shape and/or Size 6 6
Loss of or Failure to Bond 6 6
Difficult or Delayed Separation 6 6
Migration 5 5
Device Slipped 5 5
Fitting Problem 4 4
Device Damaged Prior to Use 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
Difficult to Advance 3 3
Defective Device 3 3
Malposition of Device 3 3
Degraded 3 3
Tear, Rip or Hole in Device Packaging 2 2
Pitted 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 2 2
Inaccurate Information 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Mechanics Altered 1 1
Packaging Problem 1 1
Device Difficult to Maintain 1 1
Device Damaged by Another Device 1 1
Activation, Positioning or Separation Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Failure to Align 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Unstable 1 1
Flaked 1 1
Material Disintegration 1 1
Display Difficult to Read 1 1
Labelling, Instructions for Use or Training Problem 1 1
Melted 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7677 7677
No Consequences Or Impact To Patient 1264 1264
Insufficient Information 585 585
No Code Available 125 125
No Patient Involvement 95 95
Not Applicable 65 65
No Known Impact Or Consequence To Patient 64 64
Foreign Body In Patient 30 30
No Information 29 29
Pain 23 23
Bone Fracture(s) 17 17
Unspecified Infection 14 14
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
Swelling/ Edema 2 2
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

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Jul-20-2022
2 LINK BIO CORP II Jul-25-2024
3 Materialise USA LLC II Aug-24-2022
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