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
Corroded	50	51
Insufficient Information	39	40
Device Dislodged or Dislocated	27	27
Break	18	18
Appropriate Term/Code Not Available	15	15
Adverse Event Without Identified Device or Use Problem	11	12
Detachment of Device or Device Component	8	8
Loss of Osseointegration	8	8
Material Erosion	7	10
Fracture	7	7
Material Disintegration	6	6
Naturally Worn	6	6
Noise, Audible	6	7
Patient-Device Incompatibility	5	8
Patient Device Interaction Problem	4	5
Material Frayed	4	4
Unstable	3	3
Mechanical Problem	3	3
Difficult to Remove	3	3
Material Fragmentation	2	2
Therapeutic or Diagnostic Output Failure	2	4
Positioning Problem	1	1
Material Integrity Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Loose or Intermittent Connection	1	1
Crack	1	1
Material Discolored	1	1
Shipping Damage or Problem	1	1
Peeled/Delaminated	1	1
Use of Device Problem	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Metal Related Pathology	87	93
Pain	83	90
Insufficient Information	35	35
Failure of Implant	17	19
Unspecified Infection	15	15
Loss of Range of Motion	9	10
Joint Dislocation	5	5
Osteopenia/ Osteoporosis	5	7
Osteolysis	5	7
Swelling/ Edema	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Unequal Limb Length	3	3
Unspecified Tissue Injury	3	3
Ambulation Difficulties	3	4
Neuropathy	2	2
Nausea	2	4
Dizziness	2	4
Bone Fracture(s)	2	2
Rash	2	4
Neck Pain	2	4
Nerve Damage	2	2
Dyspnea	2	4
Headache	2	4
Hypersensitivity/Allergic reaction	1	1
Cyst(s)	1	1
Synovitis	1	2
Prolapse	1	1
Muscle/Tendon Damage	1	2
Bacterial Infection	1	2