TPLC - Total Product Life Cycle

• Device: prosthesis, wrist, carpal trapezium
• Product Code: KYI
• Regulation Number: 888.3770
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ASCENSION ORTHOPEDIC
	SUBSTANTIALLY EQUIVALENT	1
ENSEMBLE ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
EXTREMITY MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	4	4
2016	3	3
2018	4	4
2019	14	14
2020	8	8
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10	10
Appropriate Term/Code Not Available	7	7
Insufficient Information	3	3
Break	3	3
Migration or Expulsion of Device	2	2
Metal Shedding Debris	2	2
Device Operates Differently Than Expected	2	2
Device Dislodged or Dislocated	2	2
Device Contamination with Chemical or Other Material	1	1
Material Integrity Problem	1	1
Nonstandard Device	1	1
Labelling, Instructions for Use or Training Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Injury	9	9
Pain	9	9
Joint Dislocation	6	6
No Known Impact Or Consequence To Patient	5	5
Bone Fracture(s)	2	2
Unspecified Infection	2	2
Discomfort	1	1
Wound Dehiscence	1	1
Ambulation Difficulties	1	1
Limited Mobility Of The Implanted Joint	1	1
Patient Problem/Medical Problem	1	1
Unspecified Tissue Injury	1	1
No Code Available	1	1
Swelling	1	1
Inflammation	1	1
No Consequences Or Impact To Patient	1	1
Burning Sensation	1	1
Test Result	1	1
Impaired Healing	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ascension Orthopedics, Inc	II	Nov-22-2010
2	Integra LifeSciences Corp.	III	Jun-21-2013
3	Wright Medical Technology, Inc.	II	Nov-25-2019