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	382	384
Device Dislodged or Dislocated	38	39
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
Material Twisted/Bent	1	1
Material Deformation	1	1
Detachment of Device or Device Component	1	1
Migration	1	1
Appropriate Term/Code Not Available	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	198	198
Pain	116	118
No Code Available	73	75
Joint Dislocation	46	46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	21
Joint Laxity	17	17
No Clinical Signs, Symptoms or Conditions	13	15
Insufficient Information	13	13
Discomfort	8	8
Foreign Body Reaction	7	9
Hematoma	6	6
Unspecified Tissue Injury	5	5
Arthritis	5	5
Fall	4	4
Fluid Discharge	4	4
Bone Fracture(s)	3	3
Post Operative Wound Infection	3	3
Hypersensitivity/Allergic reaction	2	2
Inflammation	2	2
Injury	2	4
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
Thrombosis/Thrombus	1	1
Heart Failure/Congestive Heart Failure	1	1
No Consequences Or Impact To Patient	1	1
Hemorrhage/Bleeding	1	1