TPLC - Total Product Life Cycle

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Device	knee arthroplasty implantation system
Regulation Description	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
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	53	53
Loosening of Implant Not Related to Bone-Ingrowth	28	28
Break	10	10
Patient Device Interaction Problem	10	10
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
Insufficient Information	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	79	79
No Clinical Signs, Symptoms or Conditions	23	23
Insufficient Information	10	10
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
Bone Fracture(s)	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
Sepsis	1	1
Joint Disorder	1	1
Cyst(s)	1	1
Hematoma	1	1
Inflammation	1	1
Post Operative Wound Infection	1	1
No Known Impact Or Consequence To Patient	1	1
Hemorrhage/Bleeding	1	1
Ambulation Difficulties	1	1