TPLC - Total Product Life Cycle

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Device	semi-constrained metal/polymer finger joint prosthesis
Product Code	MPK
Device Class	Humanitarian Device Exemption

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	31	31
Naturally Worn	8	8
Loose or Intermittent Connection	7	7
Break	6	6
Device Dislodged or Dislocated	5	5
Loss of Osseointegration	3	3
Particulates	2	2
Device Slipped	2	2
Fracture	2	2
Contamination /Decontamination Problem	2	2
Device Disinfection Or Sterilization Issue	2	2
Device Operates Differently Than Expected	2	2
Positioning Problem	2	2
Migration	2	2
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Component Missing	1	1
Structural Problem	1	1
Patient-Device Incompatibility	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	25	25
Injury	20	20
No Known Impact Or Consequence To Patient	16	16
Inflammation	8	8
Ossification	5	5
Failure of Implant	5	5
No Consequences Or Impact To Patient	4	4
Hypoesthesia, Arm/Hand	4	4
Bone Fracture(s)	4	4
Insufficient Information	4	4
Joint Laxity	3	3
Nerve Damage	3	3
Joint Dislocation	2	2
Unspecified Infection	2	2
No Code Available	2	2
Numbness	2	2
No Patient Involvement	1	1
Foreign Body In Patient	1	1
No Information	1	1
Death	1	1
Debris, Bone Shedding	1	1
Perforation	1	1
Loss of Range of Motion	1	1
Swelling	1	1
Osteolysis	1	1
Rupture	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Wright Medical Technology, Inc.	II	Aug-23-2022