TPLC - Total Product Life Cycle

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Device	prosthesis, shoulder, non-constrained, metal/polymer cemented
Product Code	KWT
Regulation Number	888.3650
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1080	1080
Device Dislodged or Dislocated	660	660
Insufficient Information	394	394
Fracture	321	321
Loosening of Implant Not Related to Bone-Ingrowth	249	249
Loose or Intermittent Connection	213	213
Break	183	183
Appropriate Term/Code Not Available	161	161
Detachment of Device or Device Component	136	136
Unstable	119	119
Naturally Worn	117	117
Migration or Expulsion of Device	77	77
Device Slipped	74	74
Device Operates Differently Than Expected	50	50
Migration	46	46
Detachment Of Device Component	42	42
Loss of or Failure to Bond	34	34
Improper or Incorrect Procedure or Method	28	28
Failure To Adhere Or Bond	28	28
Mechanical Jam	26	26
Patient Device Interaction Problem	22	22
Material Separation	22	22
Difficult to Insert	20	20
Malposition of Device	19	19
Patient-Device Incompatibility	18	18
Inadequacy of Device Shape and/or Size	18	18
Difficult to Remove	16	16
Positioning Problem	15	15
Material Erosion	15	15
Unintended Movement	14	14
Physical Resistance/Sticking	14	14
Loss of Osseointegration	14	14
Mechanical Problem	13	13
Microbial Contamination of Device	12	12
Disassembly	12	12
Contamination	11	11
Torn Material	9	9
Material Deformation	9	9
Noise, Audible	8	8
Component Missing	8	8
Dull, Blunt	7	7
Entrapment of Device	7	7
Material Fragmentation	7	7
Separation Failure	6	6
Material Split, Cut or Torn	6	6
Use of Device Problem	5	5
Misassembly by Users	5	5
Component Falling	5	5
Defective Device	5	5
Fitting Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	688	688
No Code Available	562	562
Pain	527	529
Unspecified Infection	421	421
Joint Dislocation	421	421
No Known Impact Or Consequence To Patient	266	266
Joint Disorder	244	244
No Information	201	201
Bone Fracture(s)	187	187
Bacterial Infection	178	178
Fall	147	147
Insufficient Information	100	100
Loss of Range of Motion	79	79
No Clinical Signs, Symptoms or Conditions	68	68
No Consequences Or Impact To Patient	56	56
Limited Mobility Of The Implanted Joint	48	48
Osteolysis	43	43
Tissue Damage	31	31
Device Embedded In Tissue or Plaque	29	29
Injury	29	29
Foreign Body In Patient	28	28
Muscle/Tendon Damage	26	26
Impaired Healing	19	19
Joint Laxity	19	19
Hematoma	18	18
Discomfort	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Necrosis	16	16
Swelling	15	15
Inadequate Osseointegration	15	15
Erosion	15	15
Reaction	14	14
Nerve Damage	14	14
Wound Dehiscence	13	13
Implant Pain	12	12
Ossification	12	12
Patient Problem/Medical Problem	12	12
Unspecified Tissue Injury	11	11
Death	11	11
Post Operative Wound Infection	10	10
Not Applicable	9	9
Osteopenia/ Osteoporosis	9	9
Cyst(s)	8	8
Tingling	8	8
Erythema	8	8
Complaint, Ill-Defined	8	8
Numbness	8	8
Ambulation Difficulties	8	8
Fracture, Arm	8	8
Pneumonia	7	7