TPLC - Total Product Life Cycle

show TPLC since

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	390	425
Insufficient Information	302	302
Appropriate Term/Code Not Available	180	180
Loosening of Implant Not Related to Bone-Ingrowth	139	164
Fracture	136	136
Loose or Intermittent Connection	120	120
Migration or Expulsion of Device	111	111
Naturally Worn	93	93
Device Dislodged or Dislocated	56	56
Unstable	36	36
Migration	31	31
Detachment of Device or Device Component	31	31
Break	24	24
Packaging Problem	20	20
Malposition of Device	20	20
Device Markings/Labelling Problem	19	19
Loss of or Failure to Bond	17	17
Difficult to Insert	17	17
Device Slipped	13	13
Inadequacy of Device Shape and/or Size	11	11
Detachment Of Device Component	8	8
Loss of Osseointegration	8	8
No Apparent Adverse Event	8	8
Patient Device Interaction Problem	8	8
Difficult To Position	7	7
Device Operates Differently Than Expected	7	7
Component Missing	5	5
Use of Device Problem	5	5
Noise, Audible	5	5
Disassembly	5	5
Improper or Incorrect Procedure or Method	5	5
Material Erosion	5	5
Material Deformation	5	5
Difficult to Remove	4	4
Failure To Adhere Or Bond	4	4
Material Integrity Problem	4	4
Unintended Movement	4	4
Contamination	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Metal Shedding Debris	3	3
Material Protrusion/Extrusion	3	3
Osseointegration Problem	3	3
Mechanical Jam	3	3
Degraded	3	3
Misconnection	3	3
Expulsion	2	2
Device Contaminated During Manufacture or Shipping	2	2
Peeled/Delaminated	2	2
Difficult to Advance	2	2
Mechanical Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	259	299
Failure of Implant	202	207
Pain	187	187
No Code Available	185	185
No Information	179	179
Bone Fracture(s)	145	145
Insufficient Information	119	119
Joint Laxity	100	100
No Known Impact Or Consequence To Patient	67	67
Loss of Range of Motion	58	58
Osteolysis	38	38
Joint Dislocation	34	34
Fall	29	29
Nerve Damage	28	28
Reaction	27	27
No Clinical Signs, Symptoms or Conditions	26	26
Tissue Damage	25	25
Ossification	21	21
No Patient Involvement	20	20
Implant Pain	17	17
Death	15	15
Injury	14	14
Osteopenia/ Osteoporosis	14	14
Limited Mobility Of The Implanted Joint	12	12
Ambulation Difficulties	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Peripheral Nervous Injury	11	31
No Consequences Or Impact To Patient	11	11
Inflammation	10	10
Fracture, Arm	10	10
Post Operative Wound Infection	10	10
Limb Fracture	9	9
Necrosis	9	9
Wound Dehiscence	9	9
Hematoma	9	9
Muscle Weakness	9	9
Sleep Dysfunction	9	9
Inadequate Osseointegration	8	8
Metal Related Pathology	8	8
Perforation	8	8
Numbness	8	8
Patient Problem/Medical Problem	8	8
Swelling	8	8
Swelling/ Edema	7	7
Discomfort	7	7
Impaired Healing	7	7
Device Embedded In Tissue or Plaque	7	7
Peroneal Nerve Palsy	6	6
Synovitis	6	6
Cramp(s) /Muscle Spasm(s)	5	5