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	88	90
Loosening of Implant Not Related to Bone-Ingrowth	36	36
Patient Device Interaction Problem	10	10
Device Appears to Trigger Rejection	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Break	5	5
Device-Device Incompatibility	4	6
Device Markings/Labelling Problem	3	3
Incorrect Measurement	3	3
Biocompatibility	3	3
Fracture	2	2
Crack	1	1
Insufficient Information	1	1
Device Fell	1	1
Positioning Problem	1	1
Scratched Material	1	1
Material Deformation	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	117	117
No Clinical Signs, Symptoms or Conditions	22	23
Insufficient Information	11	14
Foreign Body Reaction	4	4
Inadequate Osseointegration	3	3
Pain	3	3
Unspecified Tissue Injury	3	3
Unspecified Infection	2	2
Sleep Dysfunction	2	2
Bone Fracture(s)	2	2
Implant Pain	2	2
Post Operative Wound Infection	2	2
Stenosis	2	2
Swelling/ Edema	2	2
Hypersensitivity/Allergic reaction	1	1
Sepsis	1	1
Cyst(s)	1	1
Hematoma	1	1
Inflammation	1	1
Hemorrhage/Bleeding	1	1
Ambulation Difficulties	1	1