TPLC - Total Product Life Cycle

• Device: prosthesis, finger, constrained, polymer
• Regulation Description: Finger joint polymer constrained prosthesis.
• Product Code: KYJ
• Regulation Number: 888.3230
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ASCENSION ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BRM EXTREMITIES SRL
	SUBSTANTIALLY EQUIVALENT	1
KERI MEDICAL SA
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	48	48
2021	45	45
2022	39	39
2023	24	24
2024	29	29
2025	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	102	102
Fracture	35	35
Break	29	29
Device Dislodged or Dislocated	13	13
Naturally Worn	13	13
Unstable	5	5
Material Invagination	4	4
Patient-Device Incompatibility	4	4
Inadequacy of Device Shape and/or Size	3	3
Material Split, Cut or Torn	2	2
Material Deformation	2	2
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Degraded	1	1
Migration	1	1
Loss of Osseointegration	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	82	82
Insufficient Information	38	38
Joint Laxity	18	18
Loss of Range of Motion	16	16
Implant Pain	14	14
Unspecified Infection	13	13
Joint Dislocation	8	8
No Clinical Signs, Symptoms or Conditions	7	7
Malunion of Bone	5	5
Deformity/ Disfigurement	5	5
Bone Fracture(s)	3	3
Injury	3	3
Osteolysis	3	3
Pain	3	3
Swelling/ Edema	2	2
Rheumatoid Arthritis	1	1
Hypersensitivity/Allergic reaction	1	1
Arthralgia	1	1
Metal Related Pathology	1	1
Synovitis	1	1
Foreign Body In Patient	1	1
Nerve Damage	1	1
Discomfort	1	1
Numbness	1	1
Fall	1	1
Limb Fracture	1	1
Non-union Bone Fracture	1	1