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	9	11
Material Erosion	9	9
Loss of Osseointegration	5	5
Material Disintegration	5	5
Insufficient Device Problem Information	4	4
Device Dislodged or Dislocated	3	3
Fracture	2	3
Material Integrity Problem	2	2
Biocompatibility	2	2
Off-Label Use	2	2
Corroded	1	1
Break	1	1
Noise, Audible	1	1
Naturally Worn	1	1
Osseointegration Problem	1	1
No Apparent Adverse Event	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Metal Related Pathology	26	26
Pain	25	26
Insufficient Information	8	8
Osteolysis	5	5
Ambulation or Postural Difficulties	5	5
High metal ion levels	5	5
Failure of Implant	4	5
Synovitis	4	4
Swelling/ Edema	4	4
Bone Fracture(s)	3	3
Aseptic loosening	3	3
Hair Loss	2	2
Osteopenia/ Osteoporosis	2	3
Muscle/Tendon Damage	2	2
Seroma	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Unspecified Infection	2	2
Loss of Range of Motion	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Scar Tissue	1	2
Joint Impingement	1	1
Tissue Damage	1	1
Hypersensitivity/Allergic reaction	1	1
Bursitis	1	1
Nerve Damage	1	1
Pelvic Pain	1	1
Neuropathy	1	1
Reaction	1	1
Granuloma	1	1
Foreign Body In Patient	1	1
Depression	1	1
Joint Dislocation	1	1
Balance Problems	1	1
Implant Pain	1	1
Unequal Limb Length	1	1
Limb Fracture	1	2
Adhesion(s)	1	2