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	629	629
Adverse Event Without Identified Device or Use Problem	326	326
Naturally Worn	133	133
Fracture	122	122
Device Contaminated During Manufacture or Shipping	68	68
Insufficient Information	55	55
Appropriate Term/Code Not Available	48	48
Detachment of Device or Device Component	45	45
Difficult to Insert	29	29
Break	25	25
Unstable	24	24
Noise, Audible	18	18
Packaging Problem	15	15
Positioning Failure	12	12
Off-Label Use	12	12
Loosening of Implant Not Related to Bone-Ingrowth	11	11
Material Deformation	11	11
Loose or Intermittent Connection	11	11
Device-Device Incompatibility	11	11
Nonstandard Device	10	10
Scratched Material	9	9
Unintended Movement	8	8
Malposition of Device	7	7
Migration	7	7
Separation Failure	7	7
Loss of or Failure to Bond	6	6
Tear, Rip or Hole in Device Packaging	6	6
Material Erosion	6	6
Loss of Osseointegration	5	5
Biocompatibility	5	5
Fitting Problem	5	5
Inadequacy of Device Shape and/or Size	5	5
Mechanical Problem	5	5
Use of Device Problem	5	5
Difficult to Remove	5	5
Patient Device Interaction Problem	4	4
Contamination /Decontamination Problem	4	4
Connection Problem	3	3
Device Difficult to Setup or Prepare	3	3
Material Twisted/Bent	3	3
Shipping Damage or Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Degraded	2	2
Component Missing	2	2
Failure to Osseointegrate	2	2
Material Separation	2	2
Illegible Information	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Difficult to Open or Close	2	2
Deformation Due to Compressive Stress	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	547	547
No Code Available	431	431
Pain	207	207
Unspecified Infection	152	152
Injury	97	97
Insufficient Information	90	90
No Clinical Signs, Symptoms or Conditions	87	87
Osteolysis	57	57
No Patient Involvement	56	56
Foreign Body Reaction	55	55
Joint Laxity	52	52
No Information	43	43
Failure of Implant	41	41
Fall	39	39
No Known Impact Or Consequence To Patient	38	38
No Consequences Or Impact To Patient	33	33
Test Result	32	32
Tissue Damage	32	32
Ambulation Difficulties	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	28	28
Limited Mobility Of The Implanted Joint	26	26
Loss of Range of Motion	25	25
Hypersensitivity/Allergic reaction	23	23
Bone Fracture(s)	20	20
Discomfort	17	17
Not Applicable	17	17
Hematoma	14	14
Ossification	11	11
Scar Tissue	11	11
Osteopenia/ Osteoporosis	11	11
Inflammation	11	11
Edema	10	10
Adhesion(s)	10	10
Thrombosis	9	9
Inadequate Osseointegration	9	9
Unspecified Tissue Injury	8	8
Metal Related Pathology	8	8
Necrosis	7	7
Joint Disorder	7	7
Pulmonary Embolism	7	7
Weakness	7	7
Swelling	7	7
Cyst(s)	6	6
Swelling/ Edema	6	6
Impaired Healing	6	6
Reaction	6	6
Fatigue	6	6
Hemorrhage/Bleeding	5	5
Erosion	4	4
Unspecified Musculoskeletal problem	4	4