TPLC - Total Product Life Cycle

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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	381	416
Appropriate Term/Code Not Available	148	148
Loosening of Implant Not Related to Bone-Ingrowth	141	166
Fracture	94	94
Insufficient Information	80	80
Loose or Intermittent Connection	78	78
Naturally Worn	57	57
Device Dislodged or Dislocated	41	41
Unstable	30	30
Detachment of Device or Device Component	30	30
Migration	21	21
Break	19	19
Loss of or Failure to Bond	14	14
Migration or Expulsion of Device	12	12
Malposition of Device	9	9
Material Erosion	8	8
No Apparent Adverse Event	8	8
Patient Device Interaction Problem	8	8
Loss of Osseointegration	7	7
Difficult to Insert	7	7
Use of Device Problem	5	5
Osseointegration Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Unintended Movement	4	4
Device Slipped	4	4
Degraded	3	3
Material Integrity Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Positioning Failure	2	2
Packaging Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Protrusion/Extrusion	2	2
Peeled/Delaminated	2	2
Mechanical Jam	2	2
Expulsion	2	2
Noise, Audible	2	2
Microbial Contamination of Device	1	1
Material Fragmentation	1	1
Positioning Problem	1	1
Component Missing	1	1
Structural Problem	1	1
Device Damaged by Another Device	1	1
Misconnection	1	1
Delivered as Unsterile Product	1	1
Unclear Information	1	1
Patient-Device Incompatibility	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Markings/Labelling Problem	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	182	222
Failure of Implant	179	184
Insufficient Information	132	132
Joint Laxity	122	122
Pain	120	120
Bone Fracture(s)	90	90
No Information	62	62
No Known Impact Or Consequence To Patient	46	46
Loss of Range of Motion	39	39
No Code Available	33	33
Joint Dislocation	30	30
No Clinical Signs, Symptoms or Conditions	30	30
Fall	21	21
Implant Pain	18	18
Osteopenia/ Osteoporosis	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Osteolysis	12	12
Peripheral Nervous Injury	11	31
Injury	11	11
Reaction	10	10
Wound Dehiscence	9	9
Limb Fracture	9	9
Inadequate Osseointegration	9	9
Metal Related Pathology	9	9
No Consequences Or Impact To Patient	8	8
Ossification	8	8
Tissue Damage	7	7
Swelling/ Edema	7	7
Limited Mobility Of The Implanted Joint	7	7
Nerve Damage	7	7
Impaired Healing	6	6
Numbness	6	6
Tissue Breakdown	5	5
Malunion of Bone	5	5
Scar Tissue	5	5
Post Operative Wound Infection	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Patient Problem/Medical Problem	5	5
Synovitis	5	5
Fracture, Arm	5	5
Adhesion(s)	5	5
Inflammation	5	5
Blood Loss	4	4
Fistula	4	4
Swelling	4	4
Discomfort	4	4
Peroneal Nerve Palsy	4	4
Disability	4	4
Hypersensitivity/Allergic reaction	4	4
Muscle/Tendon Damage	4	4