TPLC - Total Product Life Cycle

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Device	prosthesis, hip, hemi-, femoral, metal ball
Regulation Description	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product Code	LZY
Regulation Number	888.3360
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	340	757
Device Dislodged or Dislocated	27	27
Naturally Worn	11	11
Fracture	4	4
Device Contaminated During Manufacture or Shipping	3	3
Break	2	2
Degraded	2	2
Off-Label Use	1	1
Malposition of Device	1	418
Material Twisted/Bent	1	1
Material Deformation	1	1
Detachment of Device or Device Component	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Migration	1	1
Osseointegration Problem	1	418

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	181	598
Pain	98	515
Joint Dislocation	35	452
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	21	21
Joint Laxity	18	435
Insufficient Information	15	432
No Clinical Signs, Symptoms or Conditions	11	11
Hematoma	6	6
Discomfort	6	6
Unspecified Tissue Injury	6	6
Foreign Body Reaction	5	5
Arthritis	5	5
Fluid Discharge	4	4
Bone Fracture(s)	3	3
Bone Notching	3	3
Hypersensitivity/Allergic reaction	2	2
Metal Related Pathology	2	419
Inflammation	2	2
Fall	2	2
Pocket Erosion	2	2
Muscle Weakness/Atrophy	1	1
Aseptic loosening	1	418
Arthralgia	1	1
Solid Tumour	1	418
Failure of Implant	1	1
Adhesion(s)	1	1
Cardiac Arrest	1	1
Post Operative Wound Infection	1	1
Thrombosis/Thrombus	1	1
Osteolysis	1	418
Unequal Limb Length	1	418
Hemorrhage/Blood Loss/Bleeding	1	1
Heart Failure/Congestive Heart Failure	1	1
Periprosthetic fracture	1	418
Erosion	1	418
Deformity/ Disfigurement	1	418