TPLC - Total Product Life Cycle

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Device	prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Product Code	KWZ
Regulation Number	888.3310
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	1502	1502
Insufficient Information	1119	1119
Adverse Event Without Identified Device or Use Problem	399	399
Fracture	243	243
Naturally Worn	208	208
Appropriate Term/Code Not Available	185	185
Failure To Adhere Or Bond	149	149
Migration or Expulsion of Device	114	114
Break	101	101
Corroded	99	99
Unstable	82	82
Device Contaminated During Manufacture or Shipping	68	68
Detachment of Device or Device Component	52	52
Difficult to Insert	46	46
Disassembly	45	45
Malposition of Device	43	43
Noise, Audible	30	30
Loose or Intermittent Connection	28	28
Mechanical Problem	24	24
Device Slipped	21	21
Device Operates Differently Than Expected	21	21
Material Deformation	20	20
Material Erosion	20	20
Detachment Of Device Component	19	19
Material Separation	19	19
Scratched Material	19	19
Loss of Osseointegration	18	18
Fitting Problem	18	18
Nonstandard Device	15	15
Packaging Problem	15	15
Loss of or Failure to Bond	13	13
Off-Label Use	13	13
Positioning Failure	12	12
Material Integrity Problem	11	11
Positioning Problem	11	11
Loosening of Implant Not Related to Bone-Ingrowth	11	11
Device-Device Incompatibility	11	11
Separation Failure	10	10
Difficult to Remove	10	10
Tear, Rip or Hole in Device Packaging	10	10
Improper or Incorrect Procedure or Method	10	10
Metal Shedding Debris	9	9
Migration	9	9
Use of Device Problem	9	9
Unintended Movement	9	9
Compatibility Problem	8	8
Biocompatibility	7	7
Crack	7	7
Failure to Osseointegrate	6	6
Inadequacy of Device Shape and/or Size	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	1023	1023
Joint Dislocation	918	918
No Information	878	878
Pain	577	577
Unspecified Infection	428	428
Injury	265	265
Osteolysis	122	122
Bone Fracture(s)	104	104
No Known Impact Or Consequence To Patient	100	100
Foreign Body Reaction	100	100
Fall	94	94
Insufficient Information	90	90
No Clinical Signs, Symptoms or Conditions	87	87
No Consequences Or Impact To Patient	85	85
Reaction	77	77
Ambulation Difficulties	67	67
Not Applicable	63	63
Tissue Damage	60	60
Failure of Implant	59	59
No Patient Involvement	56	56
Loss of Range of Motion	54	54
Joint Laxity	52	52
Limited Mobility Of The Implanted Joint	52	52
Discomfort	45	45
Swelling	43	43
Test Result	42	42
Inflammation	40	40
Ossification	36	36
Hematoma	36	36
Hip Fracture	30	30
Toxicity	29	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	28	28
Hypersensitivity/Allergic reaction	24	24
Death	22	22
Thrombosis	17	17
Erosion	16	16
Scar Tissue	15	15
Necrosis	14	14
Pulmonary Embolism	14	14
Edema	14	14
Inadequate Osseointegration	13	13
Impaired Healing	13	13
Osteopenia/ Osteoporosis	13	13
Host-Tissue Reaction	13	13
Metal Related Pathology	12	12
Adhesion(s)	12	12
Joint Disorder	10	10
Fatigue	10	10
Swelling/ Edema	9	9
Unspecified Tissue Injury	9	9