TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained
Product Code	LZJ
Device Class	Unclassified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Loose or Intermittent Connection	10	10
Adverse Event Without Identified Device or Use Problem	8	8
Insufficient Information	3	3
Break	2	2
Unintended Movement	2	2
Peeled/Delaminated	2	2
Therapeutic or Diagnostic Output Failure	2	2
Migration or Expulsion of Device	2	2
Device Operates Differently Than Expected	2	2
Patient-Device Incompatibility	1	1
Material Twisted/Bent	1	1
Unstable	1	1
Appropriate Term/Code Not Available	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Patient Device Interaction Problem	1	1
Mechanical Problem	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	10	10
Inadequate Pain Relief	10	10
Failure of Implant	5	5
No Known Impact Or Consequence To Patient	5	5
Loss of Range of Motion	4	4
No Code Available	3	3
Skin Infection	3	3
Reaction to Medicinal Component of Device	3	3
Joint Swelling	2	2
Malaise	1	1
Disability	1	1
Osteolysis	1	1
Unspecified Infection	1	1
No Patient Involvement	1	1
Limited Mobility Of The Implanted Joint	1	1
Scar Tissue	1	1
Swelling	1	1
Tissue Damage	1	1
Burning Sensation	1	1
Discomfort	1	1
Debris, Bone Shedding	1	1
Fatigue	1	1
Bone Fracture(s)	1	1
Headache	1	1
Hypersensitivity/Allergic reaction	1	1
Insufficient Information	1	1
No Clinical Signs, Symptoms or Conditions	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arthrosurface, Inc.	II	Dec-23-2015