TPLC - Total Product Life Cycle

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Device	prosthesis, hip, femoral, resurfacing
Regulation Description	Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
Product Code	KXA
Regulation Number	888.3400
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10	12
Material Erosion	7	7
Loss of Osseointegration	5	5
Material Disintegration	5	5
Biocompatibility	3	3
Device Dislodged or Dislocated	3	3
Fracture	3	4
Insufficient Information	3	3
Appropriate Term/Code Not Available	3	3
Output Problem	2	2
Particulates	2	2
Off-Label Use	2	2
Corroded	2	2
Material Integrity Problem	2	2
Patient-Device Incompatibility	2	2
Defective Device	1	1
Naturally Worn	1	1
Break	1	1
Flaked	1	1
Inadequacy of Device Shape and/or Size	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Osseointegration Problem	1	1
Noise, Audible	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Metal Related Pathology	23	23
Pain	23	24
Insufficient Information	8	8
Osteolysis	5	5
Failure of Implant	3	4
Bone Fracture(s)	3	3
Synovitis	3	3
Swelling/ Edema	3	3
Ambulation Difficulties	3	3
Unspecified Infection	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Osteopenia/ Osteoporosis	2	3
Hair Loss	2	2
Neuropathy	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Joint Dislocation	1	1
Adhesion(s)	1	2
Loss of Range of Motion	1	1
Depression	1	1
Scar Tissue	1	2
Balance Problems	1	1
Reaction	1	1
Limb Fracture	1	2
Muscle/Tendon Damage	1	1
Tissue Damage	1	1
Granuloma	1	1