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	481	540
Loosening of Implant Not Related to Bone-Ingrowth	163	193
Appropriate Term/Code Not Available	117	117
Fracture	90	90
Loose or Intermittent Connection	62	62
Naturally Worn	51	52
Insufficient Information	46	48
Device Dislodged or Dislocated	40	40
Unstable	36	36
Detachment of Device or Device Component	28	30
Migration	16	16
Break	13	13
Material Erosion	10	10
Patient Device Interaction Problem	10	10
Malposition of Device	7	7
Difficult to Insert	7	7
Loss of Osseointegration	6	6
Unintended Movement	5	5
Migration or Expulsion of Device	4	7
Loss of or Failure to Bond	4	4
Degraded	4	4
Use of Device Problem	4	4
Noise, Audible	3	3
Osseointegration Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Inadequacy of Device Shape and/or Size	3	3
Mechanical Jam	2	2
No Apparent Adverse Event	2	2
Material Protrusion/Extrusion	2	2
Tear, Rip or Hole in Device Packaging	2	2
Packaging Problem	2	2
Positioning Failure	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Peeled/Delaminated	2	2
Expulsion	2	2
Device Slipped	2	2
Misconnection	1	1
Failure to Osseointegrate	1	1
Component Missing	1	1
Material Separation	1	1
Material Fragmentation	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Patient-Device Incompatibility	1	1
Difficult to Open or Close	1	1
Device Markings/Labelling Problem	1	1
Crack	1	1
Off-Label Use	1	1
Flaked	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	207	215
Unspecified Infection	178	218
Joint Laxity	173	174
Insufficient Information	160	171
Pain	104	108
Bone Fracture(s)	86	88
Loss of Range of Motion	43	44
No Clinical Signs, Symptoms or Conditions	41	41
Joint Dislocation	33	33
Implant Pain	22	22
Fall	20	20
Osteolysis	15	15
Swelling/ Edema	14	14
No Code Available	14	14
No Information	14	14
Metal Related Pathology	13	13
Osteopenia/ Osteoporosis	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Peripheral Nervous Injury	12	32
No Known Impact Or Consequence To Patient	12	12
Ossification	11	11
Limb Fracture	10	10
Hematoma	10	10
Muscle/Tendon Damage	9	9
Numbness	9	9
Injury	9	9
Impaired Healing	9	9
Bacterial Infection	8	8
Inadequate Osseointegration	8	8
Scar Tissue	8	8
Adhesion(s)	7	7
Post Operative Wound Infection	7	7
Nerve Damage	7	8
Wound Dehiscence	7	7
Joint Contracture	6	10
Reaction	6	6
Muscle Weakness	5	5
Tissue Breakdown	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Synovitis	5	6
Inflammation	5	5
Foreign Body In Patient	5	5
Limited Mobility Of The Implanted Joint	5	5
Malunion of Bone	5	5
No Consequences Or Impact To Patient	4	4
Tissue Damage	4	4
Patient Problem/Medical Problem	4	4
Hypersensitivity/Allergic reaction	4	4
Arthritis	3	3
Nodule	3	3