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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, ankle, semi-constrained, cemented, metal/polymer
Regulation Description Ankle joint metal/polymer semi-constrained cemented prosthesis.
Product CodeHSN
Regulation Number 888.3110
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Implant, removal of 147
Naturally worn 76
Loose 72
Component(s), worn 41
No Known Device Problem 41
Unknown (for use when the device problem is not known) 38
No Information 32
Loss of osseointegration 27
Loose or intermittent connection 24
Loss of or failure to bond 20
Migration of device or device component 19
Other (for use when an appropriate device code cannot be identified) 14
No code available 6
Malposition of device 5
Size incorrect for patient 2
Break 2
Component(s), broken 2
Electro-magnetic interference (EMI) 2
Fracture 2
Premature explantation 1
Device remains implanted 1
Improper or incorrect procedure or method 1
Dislodged or dislocated 1
Positioning Issue 1
Unintended movement 1
Total Device Problems 578

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