TPLC - Total Product Life Cycle

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Device	prosthesis, elbow, constrained, cemented
Regulation Description	Elbow joint metal/polymer constrained cemented prosthesis.
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	369	404
Loosening of Implant Not Related to Bone-Ingrowth	130	155
Appropriate Term/Code Not Available	118	118
Fracture	78	78
Loose or Intermittent Connection	62	62
Naturally Worn	48	48
Insufficient Information	37	37
Device Dislodged or Dislocated	36	36
Unstable	29	29
Detachment of Device or Device Component	26	26
Migration	14	14
Break	13	13
Patient Device Interaction Problem	8	8
Material Erosion	8	8
Difficult to Insert	7	7
Malposition of Device	7	7
Loss of Osseointegration	6	6
Loss of or Failure to Bond	4	4
Migration or Expulsion of Device	4	4
Use of Device Problem	4	4
Inadequacy of Device Shape and/or Size	3	3
Osseointegration Problem	3	3
Unintended Movement	3	3
Improper or Incorrect Procedure or Method	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Mechanical Jam	2	2
Degraded	2	2
Peeled/Delaminated	2	2
No Apparent Adverse Event	2	2
Expulsion	2	2
Noise, Audible	2	2
Tear, Rip or Hole in Device Packaging	2	2
Device Slipped	2	2
Material Protrusion/Extrusion	2	2
Packaging Problem	2	2
Positioning Failure	2	2
Positioning Problem	1	1
Material Integrity Problem	1	1
Deformation Due to Compressive Stress	1	1
Material Separation	1	1
Device Markings/Labelling Problem	1	1
Misconnection	1	1
Difficult to Open or Close	1	1
Material Fragmentation	1	1
Component Missing	1	1
Off-Label Use	1	1
Patient-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	168	173
Unspecified Infection	153	193
Insufficient Information	137	137
Joint Laxity	126	126
Pain	94	94
Bone Fracture(s)	77	77
Loss of Range of Motion	37	37
No Clinical Signs, Symptoms or Conditions	32	32
Joint Dislocation	30	30
Fall	20	20
Implant Pain	18	18
No Code Available	14	14
No Information	14	14
No Known Impact Or Consequence To Patient	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Peripheral Nervous Injury	11	31
Osteopenia/ Osteoporosis	11	11
Osteolysis	9	9
Injury	9	9
Metal Related Pathology	9	9
Limb Fracture	9	9
Inadequate Osseointegration	8	8
Ossification	8	8
Swelling/ Edema	7	7
Wound Dehiscence	7	7
Nerve Damage	7	7
Numbness	6	6
Reaction	6	6
Inflammation	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Malunion of Bone	5	5
Synovitis	5	5
Limited Mobility Of The Implanted Joint	5	5
Scar Tissue	5	5
Tissue Breakdown	5	5
Post Operative Wound Infection	5	5
Adhesion(s)	5	5
Hypersensitivity/Allergic reaction	4	4
Muscle/Tendon Damage	4	4
Tissue Damage	4	4
Impaired Healing	4	4
Patient Problem/Medical Problem	4	4
No Consequences Or Impact To Patient	4	4
Arthritis	3	3
Nodule	3	3
Bacterial Infection	3	3
Muscle Weakness	3	3
Fracture, Arm	3	3
Non-union Bone Fracture	2	2
Discomfort	2	2