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	398	400
Device Dislodged or Dislocated	40	41
Naturally Worn	11	11
Fracture	4	4
Device Contaminated During Manufacture or Shipping	3	3
Degraded	2	2
Break	2	2
Migration	1	1
Off-Label Use	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Detachment of Device or Device Component	1	1
Material Twisted/Bent	1	1
Material Deformation	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	210	210
Pain	120	122
No Code Available	73	75
Joint Dislocation	48	48
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	21	21
Joint Laxity	17	17
Insufficient Information	14	14
No Clinical Signs, Symptoms or Conditions	13	15
Discomfort	8	8
Foreign Body Reaction	7	9
Hematoma	6	6
Unspecified Tissue Injury	6	6
Fluid Discharge	6	6
Arthritis	5	5
Fall	4	4
Post Operative Wound Infection	3	3
Bone Notching	3	3
Bone Fracture(s)	3	3
Injury	2	4
Pocket Erosion	2	2
Hypersensitivity/Allergic reaction	2	2
Inflammation	2	2
Metal Related Pathology	1	1
No Consequences Or Impact To Patient	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Arthralgia	1	1
Cardiac Arrest	1	1
Adhesion(s)	1	1
Thrombosis/Thrombus	1	1
Failure of Implant	1	1
Muscle Weakness/Atrophy	1	1
Heart Failure/Congestive Heart Failure	1	1