TPLC - Total Product Life Cycle

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Device	prosthesis, hip, hemi-, femoral, metal ball
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	357	357
Insufficient Information	251	251
Device Dislodged or Dislocated	102	102
Appropriate Term/Code Not Available	13	13
Naturally Worn	13	13
Break	4	4
Device Contaminated During Manufacture or Shipping	3	3
Migration	3	3
Inadequacy of Device Shape and/or Size	3	3
Material Deformation	2	2
Difficult to Insert	2	2
Degraded	2	2
No Apparent Adverse Event	1	1
Material Twisted/Bent	1	1
Fracture	1	1
Loss of or Failure to Bond	1	1
Disassembly	1	1
Nonstandard Device	1	1
Corroded	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	307	307
Pain	234	234
No Code Available	150	150
Joint Dislocation	67	67
No Information	49	50
Not Applicable	23	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	21
Joint Laxity	15	15
Discomfort	13	13
No Clinical Signs, Symptoms or Conditions	12	12
Hematoma	9	9
Fall	8	8
Foreign Body Reaction	6	6
Insufficient Information	6	6
Injury	5	5
Fluid Discharge	4	4
Osteolysis	4	4
Unspecified Tissue Injury	3	3
Host-Tissue Reaction	3	3
Post Operative Wound Infection	3	3
Hypersensitivity/Allergic reaction	2	2
Ambulation Difficulties	2	2
Pocket Erosion	2	2
No Consequences Or Impact To Patient	2	2
Failure of Implant	2	2
Erosion	2	2
Bone Fracture(s)	2	2
Tissue Damage	2	2
No Known Impact Or Consequence To Patient	2	2
Loss of Range of Motion	2	2
Hemorrhage/Bleeding	1	1
Phlebitis	1	1
Embolism	1	1
Heart Failure/Congestive Heart Failure	1	1
Pneumonia	1	1
Thrombosis	1	1
Swelling	1	1
Thrombosis/Thrombus	1	1
Seroma	1	1
Cardiac Arrest	1	1
Ossification	1	1
Edema	1	1
Muscle Weakness	1	1
Inflammation	1	1
Adhesion(s)	1	1
Test Result	1	1
Metal Related Pathology	1	1
Joint Disorder	1	1
Arthralgia	1	1
Hip Fracture	1	1