Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
Regulation Description Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
Product CodeJDH
Regulation Number 888.3380
Device Class 3

MDR Year MDR Reports MDR Events
2021 158 158
2022 75 76
2023 5 5
2024 6 6
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 113 113
Naturally Worn 39 39
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Biocompatibility 18 18
Fracture 14 14
Break 14 14
Device Dislodged or Dislocated 11 11
Corroded 9 9
Loose or Intermittent Connection 7 7
Loss of Osseointegration 5 5
Migration 4 4
Crack 2 2
Connection Problem 2 2
Mechanical Jam 2 2
Degraded 2 2
Malposition of Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Erosion 2 2
Separation Failure 2 2
Material Deformation 2 2
Material Twisted/Bent 1 1
Insufficient Device Problem Information 1 1
Use of Device Problem 1 2
Incomplete or Inadequate Connection 1 1
Unstable 1 1
Difficult to Insert 1 1
Fitting Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 86 86
Failure of Implant 46 46
Joint Dislocation 33 33
Metal Related Pathology 29 29
Bone Fracture(s) 20 20
Unspecified Infection 19 19
Pain 18 18
Osteolysis 12 12
Inadequate Osseointegration 10 10
Thrombosis/Thrombus 10 10
Ambulation or Postural Difficulties 8 8
Insufficient Information 8 8
Necrosis 6 6
Hip Fracture 5 5
Discomfort 5 5
Implant Pain 5 5
Loss of Range of Motion 4 4
Inflammation 4 4
Swelling/ Edema 3 3
Tissue Breakdown 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Subluxation 2 3
Nonunion/Delayed-union Bone Fracture 2 2
Post Operative Wound Infection 2 2
Hernia 1 1
Skin Infection 1 1
Fall 1 1
Infiltration into Tissue 1 1
Chest Pain 1 1
Foreign Body In Patient 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Laceration(s) 1 1
Ventricular Fibrillation 1 1
Muscle/Tendon Damage 1 1
Unspecified Heart Problem 1 1
Impaired Healing 1 1
Bacterial Infection 1 1
Deformity/ Disfigurement 1 1
Thromboembolism 1 1
Extraskeletal ossification 1 1
Joint Laxity 1 2
Sepsis 1 1
Cardiovascular Dysfunction/Insufficiency 1 1
Tachycardia 1 1
Unspecified Musculoskeletal problem 1 1

-
-