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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, wrist, hemi-, ulnar
Product CodeKXE
Regulation Number 888.3810
Device Class 2


Premarket Reviews
ManufacturerDecision
APTIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
APTIS MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSION ORTHOPEDIC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 3 3
2016 3 3
2017 5 5
2018 3 3
2019 7 7
2020 5 5
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 3 3
Shelf Life Exceeded 3 3
Break 2 2
Installation-Related Problem 2 2
Fracture 2 2
Migration or Expulsion of Device 2 2
Device Operates Differently Than Expected 1 1
Tear, Rip or Hole in Device Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Appropriate Term/Code Not Available 1 1
Detachment Of Device Component 1 1
Packaging Problem 1 1
Naturally Worn 1 1
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
No Code Available 6 6
No Information 4 4
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 3 3
Injury 2 2
Joint Dislocation 2 2
Swelling 2 2
Bone Fracture(s) 2 2
Failure of Implant 1 1
Unspecified Infection 1 1
Inflammation 1 1
Nerve Damage 1 1
Neuropathy 1 1
Discomfort 1 1
Rash 1 1
Post Operative Wound Infection 1 1
Sleep Dysfunction 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ascension Orthopedics, Inc II Feb-17-2012
2 Stryker Howmedica Osteonics Corp. II Aug-20-2015
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