TPLC - Total Product Life Cycle

show TPLC since

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	527	587
Loosening of Implant Not Related to Bone-Ingrowth	179	209
Appropriate Term/Code Not Available	117	117
Fracture	99	99
Loose or Intermittent Connection	62	62
Naturally Worn	53	54
Insufficient Information	48	50
Unstable	42	42
Device Dislodged or Dislocated	42	42
Detachment of Device or Device Component	32	34
Patient Device Interaction Problem	17	17
Migration	16	16
Break	13	13
Material Erosion	10	10
Difficult to Insert	8	8
Malposition of Device	7	7
Loss of Osseointegration	6	6
Unintended Movement	5	5
No Apparent Adverse Event	5	5
Loss of or Failure to Bond	4	4
Migration or Expulsion of Device	4	7
Degraded	4	4
Use of Device Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Noise, Audible	3	3
Osseointegration Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Mechanical Problem	3	3
Packaging Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Positioning Failure	2	2
Material Protrusion/Extrusion	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Peeled/Delaminated	2	2
Mechanical Jam	2	2
Expulsion	2	2
Device Slipped	2	2
Failure to Osseointegrate	1	1
Misconnection	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
Device Markings/Labelling Problem	1	1
Device Reprocessing Problem	1	1
Difficult to Open or Close	1	1
Crack	1	1
Flaked	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	210	218
Joint Laxity	189	190
Insufficient Information	187	198
Unspecified Infection	184	224
Pain	107	112
Bone Fracture(s)	93	96
No Clinical Signs, Symptoms or Conditions	44	44
Loss of Range of Motion	43	44
Joint Dislocation	36	36
Implant Pain	25	25
Fall	20	20
Osteolysis	17	17
No Code Available	14	14
Metal Related Pathology	14	14
Swelling/ Edema	14	14
No Information	14	14
Osteopenia/ Osteoporosis	13	13
Peripheral Nervous Injury	12	32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
No Known Impact Or Consequence To Patient	12	12
Limb Fracture	11	11
Ossification	11	11
Hematoma	10	10
Injury	9	9
Muscle/Tendon Damage	9	9
Numbness	9	9
Impaired Healing	9	9
Bacterial Infection	8	8
Inadequate Osseointegration	8	8
Nerve Damage	8	9
Scar Tissue	8	8
Adhesion(s)	7	7
Post Operative Wound Infection	7	7
Wound Dehiscence	7	7
Joint Contracture	6	10
Reaction	6	6
Inflammation	5	5
Muscle Weakness	5	5
Synovitis	5	6
Cramp(s) /Muscle Spasm(s)	5	5
Limited Mobility Of The Implanted Joint	5	5
Foreign Body In Patient	5	5
Malunion of Bone	5	5
Tissue Breakdown	5	5
Tissue Damage	4	4
No Consequences Or Impact To Patient	4	4
Hypersensitivity/Allergic reaction	4	4
Patient Problem/Medical Problem	4	4
Nodule	3	3
Non-union Bone Fracture	3	3