TPLC - Total Product Life Cycle

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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	568	568
Corroded	91	91
Device Dislodged or Dislocated	79	79
Material Disintegration	51	51
Break	35	35
Appropriate Term/Code Not Available	26	26
Loose or Intermittent Connection	21	21
Material Erosion	21	21
Naturally Worn	18	18
Detachment of Device or Device Component	18	18
Adverse Event Without Identified Device or Use Problem	17	17
Loss of Osseointegration	14	14
Fracture	14	14
Unstable	11	11
Noise, Audible	10	10
Migration or Expulsion of Device	8	8
Malposition of Device	7	7
Patient-Device Incompatibility	6	6
Material Frayed	5	5
Difficult to Remove	4	4
Metal Shedding Debris	4	4
Patient Device Interaction Problem	3	3
Migration	3	3
Mechanical Problem	3	3
Compatibility Problem	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Material Fragmentation	2	2
Therapeutic or Diagnostic Output Failure	2	2
Fitting Problem	2	2
Disassembly	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Positioning Problem	1	1
Degraded	1	1
Difficult to Insert	1	1
Shipping Damage or Problem	1	1
Material Discolored	1	1
Use of Device Problem	1	1
Material Distortion	1	1
Material Twisted/Bent	1	1
Packaging Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Crack	1	1
Computer Software Problem	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Reaction	410	410
Pain	228	228
No Information	171	171
Metal Related Pathology	94	94
Unspecified Infection	70	70
Insufficient Information	34	34
Failure of Implant	25	25
Osteolysis	19	19
Joint Dislocation	18	18
No Code Available	17	17
Loss of Range of Motion	16	16
Tissue Damage	11	11
Injury	10	10
Bone Fracture(s)	10	10
Osteopenia/ Osteoporosis	8	8
Host-Tissue Reaction	7	7
Necrosis	7	7
Foreign Body Reaction	5	5
Synovitis	5	5
Unequal Limb Length	4	4
Swelling	4	4
Fluid Discharge	3	3
Toxicity	3	3
Unspecified Tissue Injury	3	3
Swelling/ Edema	3	3
No Known Impact Or Consequence To Patient	3	3
Ossification	3	3
Local Reaction	3	3
Inflammation	3	3
Limited Mobility Of The Implanted Joint	3	3
Hip Fracture	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Keratitis	2	2
Headache	2	2
Dizziness	2	2
Rash	2	2
Neck Pain	2	2
Nerve Damage	2	2
Inadequate Osseointegration	2	2
Nausea	2	2
Discomfort	2	2
Ambulation Difficulties	2	2
Wound Dehiscence	2	2
Dyspnea	2	2
Calcium Deposits/Calcification	2	2
Sleep Dysfunction	2	2
Neuropathy	2	2
Neck Stiffness	1	1
Bacterial Infection	1	1
No Consequences Or Impact To Patient	1	1