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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, femoral component, cemented, metal
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeJDG
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1206 1206
2022 886 887
2023 289 290
2024 300 302
2025 265 265
2026 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1247 1247
Fracture 869 871
Adverse Event Without Identified Device or Use Problem 205 205
Crack 161 161
Material Twisted/Bent 125 125
Material Deformation 110 110
Naturally Worn 82 82
Detachment of Device or Device Component 80 80
Material Fragmentation 54 54
Device Dislodged or Dislocated 54 55
Incomplete or Inadequate Connection 31 31
Connection Problem 30 30
Loose or Intermittent Connection 29 29
Biocompatibility 27 27
Mechanics Altered 23 23
Mechanical Jam 22 22
Flaked 20 20
Dull, Blunt 19 19
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Scratched Material 17 17
Peeled/Delaminated 15 15
Physical Resistance/Sticking 15 15
Corroded 14 14
Mechanical Problem 12 12
Premature Separation 12 12
Component Missing 11 11
Degraded 10 10
Defective Device 8 8
Material Erosion 7 7
Difficult or Delayed Separation 7 7
Insufficient Device Problem Information 7 7
Positioning Failure 6 6
Migration 6 6
Unstable 5 5
Solder Joint Fracture 5 5
Deformation Due to Compressive Stress 5 5
Off-Label Use 5 5
Patient Device Interaction Problem 4 5
Migration or Expulsion of Device 4 4
Unsealed Device Packaging 4 4
Separation Failure 4 4
Material Separation 4 4
Material Split, Cut or Torn 3 3
Fitting Problem 3 3
Malposition of Device 3 3
Misconnection 3 3
Problem with Sterilization 3 3
Difficult to Remove 3 3
No Apparent Adverse Event 2 2
Unintended Movement 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2662 2664
Joint Dislocation 83 84
Failure of Implant 80 80
Insufficient Information 70 70
Pain 47 48
Metal Related Pathology 40 41
Unspecified Infection 33 33
Bone Fracture(s) 29 29
Inadequate Osseointegration 19 19
Foreign Body In Patient 12 12
Osteolysis 11 12
Deformity/ Disfigurement 10 10
Fall 10 10
Thrombosis/Thrombus 10 10
Ambulation or Postural Difficulties 9 9
Post Operative Wound Infection 6 6
Bacterial Infection 6 7
Subluxation 6 6
Muscle/Tendon Damage 6 7
Joint Laxity 5 5
Inflammation 5 5
Hip Fracture 5 5
Loss of Range of Motion 5 5
Nerve Damage 4 4
Fluid Discharge 4 4
Perforation 4 4
Nonunion/Delayed-union Bone Fracture 4 4
Synovitis 4 4
Medical device site infection 4 4
Device Embedded In Tissue or Plaque 4 4
Hemorrhage/Blood Loss/Bleeding 4 4
Impaired Healing 3 3
Aseptic loosening 3 3
Malunion of Bone 3 3
Swelling/ Edema 3 3
Extraskeletal ossification 3 3
Foreign Body Reaction 3 3
Laceration(s) 3 3
Confusion/ Disorientation 3 3
Joint Impingement 2 2
Unspecified Tissue Injury 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Implant Pain 2 2
Balance Problems 2 2
Necrosis 2 2
Osteopenia/ Osteoporosis 2 2
High metal ion levels 2 2
Unequal Limb Length 2 2
Dizziness 2 2
Purulent Discharge 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Feb-17-2022
2 Howmedica Osteonics Corp. II Nov-30-2021
3 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-11-2025
4 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-14-2024
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