TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, elbow, constrained, cemented
Product Code	JDC
Regulation Number	888.3150
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	357	392
Loosening of Implant Not Related to Bone-Ingrowth	128	153
Appropriate Term/Code Not Available	118	118
Fracture	75	75
Loose or Intermittent Connection	62	62
Naturally Worn	48	48
Insufficient Information	36	36
Device Dislodged or Dislocated	36	36
Unstable	28	28
Detachment of Device or Device Component	26	26
Migration	14	14
Break	13	13
Material Erosion	8	8
Patient Device Interaction Problem	8	8
Malposition of Device	7	7
Difficult to Insert	7	7
Loss of Osseointegration	6	6
Migration or Expulsion of Device	4	4
Loss of or Failure to Bond	4	4
Use of Device Problem	4	4
Osseointegration Problem	3	3
Unintended Movement	3	3
Improper or Incorrect Procedure or Method	3	3
Inadequacy of Device Shape and/or Size	3	3
Noise, Audible	2	2
Mechanical Jam	2	2
No Apparent Adverse Event	2	2
Material Protrusion/Extrusion	2	2
Packaging Problem	2	2
Positioning Failure	2	2
Degraded	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Peeled/Delaminated	2	2
Expulsion	2	2
Device Slipped	2	2
Misconnection	1	1
Component Missing	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Fragmentation	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Difficult to Open or Close	1	1
Patient-Device Incompatibility	1	1
Device Markings/Labelling Problem	1	1
Deformation Due to Compressive Stress	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	164	169
Unspecified Infection	150	190
Insufficient Information	130	130
Joint Laxity	122	122
Pain	94	94
Bone Fracture(s)	77	77
Loss of Range of Motion	37	37
Joint Dislocation	30	30
No Clinical Signs, Symptoms or Conditions	30	30
Fall	20	20
Implant Pain	18	18
No Code Available	14	14
No Information	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
No Known Impact Or Consequence To Patient	12	12
Peripheral Nervous Injury	11	31
Osteopenia/ Osteoporosis	11	11
Osteolysis	9	9
Limb Fracture	9	9
Injury	9	9
Metal Related Pathology	9	9
Inadequate Osseointegration	8	8
Ossification	8	8
Nerve Damage	7	7
Swelling/ Edema	7	7
Wound Dehiscence	7	7
Reaction	6	6
Numbness	6	6
Synovitis	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Inflammation	5	5
Post Operative Wound Infection	5	5
Adhesion(s)	5	5
Limited Mobility Of The Implanted Joint	5	5
Malunion of Bone	5	5
Scar Tissue	5	5
Tissue Breakdown	5	5
Tissue Damage	4	4
Muscle/Tendon Damage	4	4
No Consequences Or Impact To Patient	4	4
Hypersensitivity/Allergic reaction	4	4
Patient Problem/Medical Problem	4	4
Impaired Healing	4	4
Nodule	3	3
Bacterial Infection	3	3
Arthritis	3	3
Muscle Weakness	3	3
Fracture, Arm	3	3
Unequal Limb Length	2	2
No Patient Involvement	2	2