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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device joint, temporomandibular, implant
Regulation Description Total temporomandibular joint prosthesis.
Definition Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
Product CodeLZD
Regulation Number 872.3940
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
2 1 1 1 2 0

MDR Year MDR Reports MDR Events
2020 255 255
2021 207 207
2022 193 193
2023 236 236
2024 207 207
2025 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 794 794
Device Dislodged or Dislocated 86 86
Malposition of Device 72 72
Patient Device Interaction Problem 65 65
Insufficient Information 57 57
Fracture 36 36
Inadequacy of Device Shape and/or Size 34 34
Device Appears to Trigger Rejection 32 32
Patient-Device Incompatibility 30 30
Noise, Audible 29 29
Migration 26 26
Loosening of Implant Not Related to Bone-Ingrowth 25 25
Migration or Expulsion of Device 16 16
Loss of Osseointegration 15 15
Positioning Problem 13 13
No Apparent Adverse Event 10 10
Fitting Problem 10 10
Difficult to Insert 7 7
Positioning Failure 7 7
Material Integrity Problem 6 6
Appropriate Term/Code Not Available 6 6
Installation-Related Problem 5 5
Loose or Intermittent Connection 5 5
Use of Device Problem 4 4
Unintended Movement 4 4
Osseointegration Problem 4 4
Product Quality Problem 2 2
Detachment of Device or Device Component 2 2
Nonstandard Device 2 2
Naturally Worn 2 2
Component Incompatible 2 2
Device-Device Incompatibility 2 2
Component Missing 1 1
Contamination 1 1
Material Perforation 1 1
Use of Incorrect Control/Treatment Settings 1 1
Device Handling Problem 1 1
Expiration Date Error 1 1
Activation, Positioning or Separation Problem 1 1
Unstable 1 1
Device Slipped 1 1
Unexpected Therapeutic Results 1 1
Connection Problem 1 1
Flaked 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 357 357
Insufficient Information 190 190
Unspecified Infection 177 177
No Clinical Signs, Symptoms or Conditions 140 140
Loss of Range of Motion 124 124
Joint Dislocation 115 115
Swelling/ Edema 95 95
Ossification 61 61
Failure of Implant 61 61
No Information 60 60
Ankylosis 59 59
Implant Pain 59 59
Bacterial Infection 43 43
Hypersensitivity/Allergic reaction 36 36
Joint Disorder 27 27
Inadequate Pain Relief 22 22
Discomfort 21 21
Numbness 21 21
Difficulty Chewing 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Inadequate Osseointegration 17 17
Scar Tissue 16 16
Headache 15 15
Obstruction/Occlusion 15 15
Swelling 14 14
Limited Mobility Of The Implanted Joint 14 14
Nerve Damage 14 14
Difficulty Chewing 12 12
Deformity/ Disfigurement 12 12
Osteolysis 10 10
Hearing Impairment 9 9
Cramp(s) /Muscle Spasm(s) 8 8
Bone Fracture(s) 8 8
Joint Laxity 8 8
Facial Nerve Paralysis 8 8
Itching Sensation 7 7
Fistula 7 7
Reaction 6 6
Abscess 6 6
Fluid Discharge 6 6
Bruxism 6 6
Feeding Problem 6 6
Perforation 5 5
Erythema 5 5
Peripheral Nervous Injury 4 4
Vertigo 4 4
Arthritis 4 4
Increased Sensitivity 4 4
Foreign Body In Patient 4 4
Paresthesia 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Leibinger GmbH & Co. KG II Mar-08-2023
2 TMJ Solutions Inc II Sep-26-2024
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