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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
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1046 1046
2021 1206 1206
2022 886 886
2023 289 289
2024 301 301
2025 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1671 1671
Fracture 681 681
Material Twisted/Bent 214 214
Adverse Event Without Identified Device or Use Problem 209 209
Crack 192 192
Material Deformation 160 160
Naturally Worn 106 106
Connection Problem 85 85
Detachment of Device or Device Component 73 73
Defective Device 73 73
Material Fragmentation 72 72
Device Dislodged or Dislocated 53 53
Loose or Intermittent Connection 49 49
Mechanical Problem 48 48
Incomplete or Inadequate Connection 41 41
Dull, Blunt 38 38
Mechanics Altered 38 38
Mechanical Jam 32 32
Flaked 25 25
Biocompatibility 24 24
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Material Separation 18 18
Physical Resistance/Sticking 18 18
Peeled/Delaminated 17 17
Corroded 17 17
Scratched Material 17 17
Component Missing 15 15
Material Disintegration 14 14
Degraded 13 13
Insufficient Information 10 10
Premature Separation 9 9
Deformation Due to Compressive Stress 8 8
Activation, Positioning or Separation Problem 8 8
Solder Joint Fracture 8 8
Inadequacy of Device Shape and/or Size 8 8
Unstable 7 7
Material Erosion 7 7
Nonstandard Device 7 7
Appropriate Term/Code Not Available 6 6
Migration 6 6
Difficult or Delayed Separation 6 6
Failure to Align 5 5
Separation Failure 5 5
Positioning Failure 5 5
Migration or Expulsion of Device 4 4
Misconnection 4 4
Device Damaged Prior to Use 4 4
Off-Label Use 4 4
Malposition of Device 4 4
Material Integrity Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2743 2743
No Known Impact Or Consequence To Patient 350 350
No Patient Involvement 237 237
No Consequences Or Impact To Patient 119 119
Failure of Implant 91 91
Joint Dislocation 81 81
Insufficient Information 65 65
Pain 47 47
Metal Related Pathology 37 37
Unspecified Infection 36 36
Bone Fracture(s) 30 30
No Information 27 27
Foreign Body In Patient 25 25
Injury 23 23
Inadequate Osseointegration 19 19
Osteolysis 11 11
Deformity/ Disfigurement 10 10
Thrombosis/Thrombus 10 10
Fall 9 9
No Code Available 8 8
Foreign Body Reaction 7 7
Subluxation 6 6
Ambulation Difficulties 6 6
Loss of Range of Motion 5 5
Device Embedded In Tissue or Plaque 5 5
Post Operative Wound Infection 5 5
Hip Fracture 5 5
Bacterial Infection 5 5
Inflammation 5 5
Perforation 4 4
Non-union Bone Fracture 4 4
Swelling/ Edema 4 4
Hemorrhage/Bleeding 4 4
Muscle/Tendon Damage 4 4
Confusion/ Disorientation 3 3
Joint Laxity 3 3
Nerve Damage 3 3
Impaired Healing 3 3
Fluid Discharge 3 3
Malunion of Bone 3 3
Osteopenia/ Osteoporosis 2 2
Implant Pain 2 2
Ossification 2 2
Synovitis 2 2
Unspecified Tissue Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Dizziness 2 2
Balance Problems 2 2
Laceration(s) 2 2
Tissue Breakdown 1 1

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 Mar-14-2024
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