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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, semi-constrained, composite/metal
Product CodeKMC
Regulation Number 888.3340
Device Class 2

MDR Year MDR Reports MDR Events
2014 3 3
2015 1 1
2016 1 1
2017 2 2
2018 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 3 3
Device Dislodged or Dislocated 2 2
Fracture 2 2
Insufficient Information 2 2
Noise, Audible 1 1
Material Erosion 1 1
Migration or Expulsion of Device 1 1
Unstable 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Tissue Damage 2 2
Toxicity 2 2
Ambulation Difficulties 2 2
No Information 2 2
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Joint Dislocation 1 1
Osteolysis 1 1
Loss of Range of Motion 1 1
Swelling 1 1
Bone Fracture(s) 1 1
Unspecified Infection 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer, Inc. II Feb-20-2014
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