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	320	320
Device Dislodged or Dislocated	26	26
Naturally Worn	11	11
Fracture	5	5
Device Contaminated During Manufacture or Shipping	3	3
Break	2	2
Degraded	2	2
Appropriate Term/Code Not Available	1	1
Migration	1	1
Material Deformation	1	1
Material Twisted/Bent	1	1
Difficult to Insert	1	1
Off-Label Use	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	165	165
Pain	93	93
Joint Dislocation	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	21
Joint Laxity	17	17
Insufficient Information	13	13
No Clinical Signs, Symptoms or Conditions	12	12
Hematoma	6	6
Discomfort	6	6
Foreign Body Reaction	5	5
Unspecified Tissue Injury	5	5
Arthritis	5	5
Fluid Discharge	4	4
Bone Fracture(s)	3	3
Hypersensitivity/Allergic reaction	2	2
Inflammation	2	2
Fall	2	2
Pocket Erosion	2	2
Arthralgia	1	1
Failure of Implant	1	1
Metal Related Pathology	1	1
Adhesion(s)	1	1
Muscle Weakness	1	1
Cardiac Arrest	1	1
Post Operative Wound Infection	1	1
Thrombosis/Thrombus	1	1
Heart Failure/Congestive Heart Failure	1	1
Hemorrhage/Bleeding	1	1