TPLC - Total Product Life Cycle

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Device	prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Description	Hip joint metal/polymer constrained cemented or uncemented prosthesis.
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	485	485
Adverse Event Without Identified Device or Use Problem	268	272
Fracture	101	105
Device Contaminated During Manufacture or Shipping	68	68
Naturally Worn	55	55
Detachment of Device or Device Component	49	49
Appropriate Term/Code Not Available	30	30
Difficult to Insert	28	28
Unstable	27	27
Insufficient Information	20	20
Packaging Problem	15	15
Break	14	14
Off-Label Use	12	12
Noise, Audible	12	12
Loosening of Implant Not Related to Bone-Ingrowth	12	12
Device-Device Incompatibility	11	11
Positioning Failure	11	11
Material Deformation	10	10
Unintended Movement	8	8
Material Erosion	7	7
Scratched Material	7	7
Migration	6	6
Tear, Rip or Hole in Device Packaging	6	6
Mechanical Problem	5	5
Difficult to Remove	4	4
Contamination /Decontamination Problem	4	4
Patient Device Interaction Problem	4	4
Separation Failure	3	3
Device Difficult to Setup or Prepare	3	3
Use of Device Problem	3	3
Osseointegration Problem	2	6
Deformation Due to Compressive Stress	2	2
Improper or Incorrect Procedure or Method	2	2
Difficult to Open or Close	2	2
Illegible Information	2	2
Inadequacy of Device Shape and/or Size	2	2
Degraded	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Defective Device	2	2
Malposition of Device	2	2
Difficult or Delayed Separation	1	1
Delivered as Unsterile Product	1	1
Problem with Sterilization	1	1
Material Twisted/Bent	1	1
Material Separation	1	1
No Apparent Adverse Event	1	1
Component Missing	1	1
Shipping Damage or Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	457	461
No Code Available	122	122
Insufficient Information	114	118
Pain	102	106
Unspecified Infection	99	103
No Clinical Signs, Symptoms or Conditions	99	99
Joint Laxity	73	73
No Patient Involvement	54	54
Failure of Implant	44	44
Fall	37	37
Ambulation Difficulties	34	34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
No Known Impact Or Consequence To Patient	26	26
Injury	21	21
Osteolysis	17	17
Foreign Body Reaction	16	16
No Consequences Or Impact To Patient	15	15
Bone Fracture(s)	15	15
No Information	12	12
Loss of Range of Motion	12	12
Hematoma	11	11
Osteopenia/ Osteoporosis	9	9
Metal Related Pathology	8	8
Scar Tissue	7	7
Adhesion(s)	7	7
Inflammation	7	7
Unspecified Tissue Injury	6	6
Limited Mobility Of The Implanted Joint	6	6
Discomfort	6	6
Weakness	6	6
Edema	6	6
Ossification	6	6
Hemorrhage/Bleeding	5	5
Swelling/ Edema	5	5
Unspecified Musculoskeletal problem	5	5
Deformity/ Disfigurement	4	4
Tissue Damage	4	4
Muscle/Tendon Damage	4	4
Thrombosis	4	4
Not Applicable	4	4
Fatigue	4	4
Hypersensitivity/Allergic reaction	4	4
Impaired Healing	3	3
Pulmonary Embolism	3	3
Test Result	3	3
Necrosis	3	3
Rheumatoid Arthritis	3	3
Unequal Limb Length	3	3
Reaction	3	3
Limb Fracture	3	3