TPLC - Total Product Life Cycle

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Device	knee arthroplasty implantation system
Definition	Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Product Code	OOG
Regulation Number	888.3560
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	46	46
Loosening of Implant Not Related to Bone-Ingrowth	24	24
Break	20	20
Adverse Event Without Identified Device or Use Problem	16	16
Compatibility Problem	12	12
Patient Device Interaction Problem	11	11
Insufficient Information	10	10
Device Appears to Trigger Rejection	8	8
Loose or Intermittent Connection	7	7
Device-Device Incompatibility	5	5
Fracture	4	4
Unstable	3	3
Incorrect Measurement	3	3
Component Missing	2	2
Delivered as Unsterile Product	2	2
Material Deformation	2	2
Device Operates Differently Than Expected	2	2
Nonstandard Device	2	2
Device Slipped	1	1
Entrapment of Device	1	1
Malposition of Device	1	1
Crack	1	1
Physical Property Issue	1	1
Device Fell	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Scratched Material	1	1
Failure To Adhere Or Bond	1	1
Device Packaging Compromised	1	1
Material Rupture	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Application Network Problem	1	1
Detachment Of Device Component	1	1
Loss of Osseointegration	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	71	71
Pain	26	26
No Known Impact Or Consequence To Patient	22	22
No Clinical Signs, Symptoms or Conditions	21	21
Unspecified Infection	17	17
Limited Mobility Of The Implanted Joint	13	13
Patient Problem/Medical Problem	12	12
No Code Available	11	11
Insufficient Information	8	8
No Information	5	5
Joint Disorder	4	4
Foreign Body Reaction	4	4
Inadequate Osseointegration	3	3
Unspecified Tissue Injury	3	3
No Consequences Or Impact To Patient	3	3
Sleep Dysfunction	2	2
Bone Fracture(s)	2	2
Implant Pain	2	2
Stenosis	2	2
Swelling/ Edema	2	2
Ambulation Difficulties	2	2
Hypersensitivity/Allergic reaction	1	1
Sepsis	1	1
Cyst(s)	1	1
Hematoma	1	1
Inflammation	1	1
Rash	1	1
Weakness	1	1
Injury	1	1
Nerve Damage	1	1
Discomfort	1	1
Reaction	1	1
Hemorrhage/Bleeding	1	1
Fibrosis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ConforMIS, Inc.	II	Oct-21-2015