TPLC - Total Product Life Cycle

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Device	prosthesis, hip, semi-constrained (metal cemented acetabular component)
Regulation Description	Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
Product Code	JDL
Regulation Number	888.3320
Device Class	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	74	75
Corroded	70	71
Device Dislodged or Dislocated	33	33
Material Disintegration	28	28
Break	21	21
Appropriate Term/Code Not Available	18	18
Detachment of Device or Device Component	13	13
Loss of Osseointegration	12	12
Adverse Event Without Identified Device or Use Problem	11	12
Material Erosion	10	13
Fracture	9	9
Naturally Worn	8	8
Noise, Audible	6	7
Unstable	5	5
Patient-Device Incompatibility	5	8
Therapeutic or Diagnostic Output Failure	5	7
Material Fragmentation	5	5
Material Frayed	4	4
Mechanical Problem	4	4
Malposition of Device	4	4
Patient Device Interaction Problem	4	5
Leak/Splash	3	3
Entrapment of Device	3	3
Difficult to Remove	3	3
Compatibility Problem	2	2
Fitting Problem	1	1
Device-Device Incompatibility	1	1
Crack	1	1
Peeled/Delaminated	1	1
Material Integrity Problem	1	1
Positioning Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Difficult to Insert	1	1
Shipping Damage or Problem	1	1
Material Discolored	1	1
Use of Device Problem	1	1
Packaging Problem	1	1
Migration	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	107	114
Metal Related Pathology	99	105
Insufficient Information	36	36
No Information	33	33
Reaction	22	22
Failure of Implant	21	23
Unspecified Infection	18	18
Loss of Range of Motion	13	14
Joint Dislocation	6	6
Osteolysis	6	8
Headache	5	7
Dyspnea	5	7
Osteopenia/ Osteoporosis	5	7
Tissue Damage	4	4
Swelling/ Edema	4	4
Unequal Limb Length	4	4
Ambulation Difficulties	3	4
Infiltration into Tissue	3	3
Unspecified Tissue Injury	3	3
Foreign Body In Patient	3	3
Injury	3	3
Foreign Body Reaction	3	3
Cognitive Changes	3	3
No Clinical Signs, Symptoms or Conditions	3	3
No Code Available	3	3
Fatigue	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Rash	2	4
Neck Pain	2	4
Local Reaction	2	2
Nerve Damage	2	2
Synovitis	2	3
Swelling	2	2
Bone Fracture(s)	2	2
Dizziness	2	4
Toxicity	2	2
Nausea	2	4
Neuropathy	2	2
No Known Impact Or Consequence To Patient	1	1
Cyst(s)	1	1
Necrosis	1	1
Prolapse	1	1
Fluid Discharge	1	1
Muscle/Tendon Damage	1	2
Host-Tissue Reaction	1	1
Hypersensitivity/Allergic reaction	1	1
Bacterial Infection	1	2
Wound Dehiscence	1	1