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	386	421
Loosening of Implant Not Related to Bone-Ingrowth	139	164
Appropriate Term/Code Not Available	118	118
Fracture	81	81
Loose or Intermittent Connection	62	62
Naturally Worn	48	48
Insufficient Information	41	41
Device Dislodged or Dislocated	38	38
Unstable	29	29
Detachment of Device or Device Component	26	26
Migration	16	16
Break	13	13
Material Erosion	10	10
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
Tear, Rip or Hole in Device Packaging	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
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	181	186
Unspecified Infection	158	198
Insufficient Information	142	142
Joint Laxity	133	133
Pain	98	98
Bone Fracture(s)	79	79
Loss of Range of Motion	39	39
No Clinical Signs, Symptoms or Conditions	33	33
Joint Dislocation	32	32
Fall	20	20
Implant Pain	18	18
Swelling/ Edema	14	14
No Code Available	14	14
No Information	14	14
Peripheral Nervous Injury	13	33
Osteolysis	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
No Known Impact Or Consequence To Patient	12	12
Ossification	11	11
Osteopenia/ Osteoporosis	11	11
Muscle/Tendon Damage	9	9
Limb Fracture	9	9
Numbness	9	9
Injury	9	9
Impaired Healing	9	9
Metal Related Pathology	9	9
Bacterial Infection	8	8
Inadequate Osseointegration	8	8
Wound Dehiscence	7	7
Nerve Damage	7	7
Reaction	6	6
Hematoma	6	6
Tissue Breakdown	5	5
Malunion of Bone	5	5
Scar Tissue	5	5
Limited Mobility Of The Implanted Joint	5	5
Adhesion(s)	5	5
Post Operative Wound Infection	5	5
Inflammation	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Synovitis	5	5
Hypersensitivity/Allergic reaction	4	4
Patient Problem/Medical Problem	4	4
Tissue Damage	4	4
No Consequences Or Impact To Patient	4	4
Muscle Weakness	3	3
Nodule	3	3
Fracture, Arm	3	3
Arthritis	3	3
Discomfort	2	2