TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, hip, semi-constrained (metal cemented acetabular component)
Product Code	JDL
Regulation Number	888.3320
Device Class	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	145	145
Corroded	69	69
Material Disintegration	46	46
Device Dislodged or Dislocated	46	46
Break	19	19
Appropriate Term/Code Not Available	18	18
Detachment of Device or Device Component	14	14
Material Erosion	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Loss of Osseointegration	12	12
Naturally Worn	12	12
Fracture	9	9
Unstable	6	6
Patient-Device Incompatibility	6	6
Noise, Audible	6	6
Material Frayed	5	5
Malposition of Device	4	4
Patient Device Interaction Problem	3	3
Loose or Intermittent Connection	3	3
Difficult to Remove	3	3
Migration	3	3
Therapeutic or Diagnostic Output Failure	2	2
Mechanical Problem	2	2
Material Fragmentation	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Compatibility Problem	2	2
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Positioning Problem	1	1
Device-Device Incompatibility	1	1
Crack	1	1
Degraded	1	1
Material Discolored	1	1
Difficult to Insert	1	1
Shipping Damage or Problem	1	1
Fitting Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	116	116
Reaction	98	98
Metal Related Pathology	86	86
No Information	57	57
Insufficient Information	30	30
Unspecified Infection	30	30
Failure of Implant	23	23
Loss of Range of Motion	14	14
Joint Dislocation	11	11
Tissue Damage	8	8
Osteolysis	7	7
Injury	6	6
Bone Fracture(s)	5	5
Necrosis	4	4
Swelling	4	4
Synovitis	4	4
Unequal Limb Length	4	4
Unspecified Tissue Injury	3	3
No Code Available	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Toxicity	3	3
Local Reaction	3	3
Osteopenia/ Osteoporosis	3	3
Limited Mobility Of The Implanted Joint	2	2
Fluid Discharge	2	2
No Known Impact Or Consequence To Patient	2	2
Neck Pain	2	2
Dizziness	2	2
Discomfort	2	2
Nerve Damage	2	2
Neuropathy	2	2
Rash	2	2
Dyspnea	2	2
Nausea	2	2
Headache	2	2
Wound Dehiscence	2	2
Ossification	2	2
Swelling/ Edema	2	2
Muscle/Tendon Damage	1	1
Impaired Healing	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Adhesion(s)	1	1
Bacterial Infection	1	1
Cyst(s)	1	1
Host-Tissue Reaction	1	1
Hypersensitivity/Allergic reaction	1	1
Hip Fracture	1	1
Scar Tissue	1	1
Tentorial Tears	1	1
Neck Stiffness	1	1
Prolapse	1	1
Ambulation Difficulties	1	1