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	49	49
Loosening of Implant Not Related to Bone-Ingrowth	28	28
Break	10	10
Patient Device Interaction Problem	9	9
Device Appears to Trigger Rejection	8	8
Adverse Event Without Identified Device or Use Problem	6	6
Device-Device Incompatibility	4	4
Incorrect Measurement	3	3
Biocompatibility	3	3
Fracture	2	2
Crack	1	1
Device Fell	1	1
Defective Device	1	1
Positioning Problem	1	1
Scratched Material	1	1
Material Deformation	1	1
Material Separation	1	1
Application Network Problem	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	77	77
No Clinical Signs, Symptoms or Conditions	23	23
Insufficient Information	8	8
Foreign Body Reaction	4	4
Pain	4	4
Inadequate Osseointegration	3	3
Unspecified Tissue Injury	3	3
Unspecified Infection	2	2
Sleep Dysfunction	2	2
Implant Pain	2	2
Stenosis	2	2
Swelling/ Edema	2	2
No Consequences Or Impact To Patient	2	2
Hypersensitivity/Allergic reaction	1	1
Joint Disorder	1	1
Sepsis	1	1
Cyst(s)	1	1
Bone Fracture(s)	1	1
Inflammation	1	1
Hematoma	1	1
No Known Impact Or Consequence To Patient	1	1
Hemorrhage/Bleeding	1	1
Ambulation Difficulties	1	1