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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 2

MDR Year MDR Reports MDR Events
2019 333 333
2020 1046 1046
2021 1206 1206
2022 886 887
2023 289 290
2024 300 302
2025 265 265
2026 143 143

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1825 1825
Fracture 923 925
Adverse Event Without Identified Device or Use Problem 302 302
Material Twisted/Bent 213 213
Crack 194 194
Material Deformation 175 175
Naturally Worn 115 115
Connection Problem 94 94
Device Dislodged or Dislocated 86 87
Detachment of Device or Device Component 85 85
Defective Device 73 73
Material Fragmentation 73 73
Insufficient Device Problem Information 61 61
Loose or Intermittent Connection 50 50
Mechanical Problem 49 49
Incomplete or Inadequate Connection 41 41
Mechanics Altered 41 41
Biocompatibility 39 39
Dull, Blunt 39 39
Mechanical Jam 36 36
Unstable 28 28
Corroded 28 28
Flaked 27 27
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Degraded 24 24
Physical Resistance/Sticking 18 18
Material Separation 18 18
Scratched Material 18 18
Peeled/Delaminated 17 17
Component Missing 15 15
Material Disintegration 14 14
Premature Separation 12 12
Deformation Due to Compressive Stress 9 9
Material Erosion 9 9
Migration 9 9
Appropriate Device Problem Term/Code Not Available 9 9
Inadequacy of Device Shape and/or Size 9 9
Loss of Osseointegration 8 8
Solder Joint Fracture 8 8
Activation, Positioning or Separation Problem 8 8
Failure to Align 7 7
Nonstandard Device 7 7
Difficult or Delayed Separation 7 7
Positioning Failure 6 6
Separation Failure 6 6
Off-Label Use 5 5
Material Integrity Problem 5 5
Noise, Audible 4 4
Loss of or Failure to Bond 4 4
Material Split, Cut or Torn 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3060 3062
No Known Impact Or Consequence To Patient 353 353
No Patient Involvement 237 237
No Consequences Or Impact To Patient 207 207
Joint Dislocation 114 115
No Code Available 104 104
Pain 102 103
Injury 101 101
Failure of Implant 100 100
Unspecified Infection 75 75
Insufficient Information 70 70
No Information 46 46
Bone Fracture(s) 46 46
Metal Related Pathology 42 43
Test Result 41 41
Tissue Damage 34 34
Foreign Body In Patient 29 29
Inadequate Osseointegration 26 26
Osteolysis 24 25
Limited Mobility Of The Implanted Joint 17 17
Inflammation 17 17
Foreign Body Reaction 14 14
Loss of Range of Motion 14 14
Fall 14 14
Discomfort 12 12
Ambulation or Postural Difficulties 11 11
Deformity/ Disfigurement 11 11
Thrombosis/Thrombus 10 10
Device Embedded In Tissue or Plaque 7 7
Hip Fracture 7 7
Post Operative Wound Infection 6 6
Swelling 6 6
Reaction 6 6
Bacterial Infection 6 7
Subluxation 6 6
Muscle/Tendon Damage 6 7
Necrosis 5 5
Nerve Damage 5 5
Joint Laxity 5 5
Hemorrhage/Blood Loss/Bleeding 4 4
Perforation 4 4
Synovitis 4 4
Death 4 4
Scar Tissue 4 4
Nonunion/Delayed-union Bone Fracture 4 4
Fluid Discharge 4 4
Medical device site infection 4 4
Fatigue 4 4
Swelling/ Edema 4 4
Laceration(s) 3 3

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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