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
Loosening of Implant Not Related to Bone-Ingrowth	23	23
Compatibility Problem	12	12
Break	11	11
Patient-Device Incompatibility	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Patient Device Interaction Problem	5	5
Device-Device Incompatibility	4	4
Incorrect Measurement	2	2
Material Separation	1	1
Loss of Osseointegration	1	1
Defective Device	1	1
Application Network Problem	1	1
Biocompatibility	1	1
Detachment of Device or Device Component	1	1
Scratched Material	1	1
Crack	1	1
Material Deformation	1	1
Device Fell	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	20	20
Pain	18	18
No Clinical Signs, Symptoms or Conditions	16	16
Unspecified Infection	13	13
Limited Mobility Of The Implanted Joint	13	13
Patient Problem/Medical Problem	12	12
Insufficient Information	6	6
Inadequate Osseointegration	3	3
Joint Disorder	3	3
Sleep Dysfunction	2	2
No Consequences Or Impact To Patient	2	2
Stenosis	2	2
No Known Impact Or Consequence To Patient	2	2
Unspecified Tissue Injury	2	2
Implant Pain	2	2
Swelling/ Edema	2	2
Ambulation Difficulties	1	1
Inflammation	1	1
Sepsis	1	1
Cyst(s)	1	1
Bone Fracture(s)	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1