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	425	425
Adverse Event Without Identified Device or Use Problem	222	222
Fracture	90	90
Device Contaminated During Manufacture or Shipping	68	68
Naturally Worn	52	52
Detachment of Device or Device Component	43	43
Appropriate Term/Code Not Available	30	30
Difficult to Insert	22	22
Unstable	20	20
Insufficient Information	18	18
Packaging Problem	15	15
Break	14	14
Noise, Audible	12	12
Loosening of Implant Not Related to Bone-Ingrowth	12	12
Positioning Failure	11	11
Material Deformation	10	10
Off-Label Use	10	10
Device-Device Incompatibility	10	10
Unintended Movement	8	8
Scratched Material	6	6
Tear, Rip or Hole in Device Packaging	6	6
Migration	6	6
Material Erosion	5	5
Mechanical Problem	5	5
Difficult to Remove	4	4
Contamination /Decontamination Problem	4	4
Patient Device Interaction Problem	4	4
Device Difficult to Setup or Prepare	3	3
Use of Device Problem	3	3
Separation Failure	3	3
Degraded	2	2
Deformation Due to Compressive Stress	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Difficult to Open or Close	2	2
Defective Device	2	2
Inadequacy of Device Shape and/or Size	2	2
Malposition of Device	2	2
Illegible Information	2	2
Mechanical Jam	1	1
Loose or Intermittent Connection	1	1
Loss of or Failure to Bond	1	1
Loss of Osseointegration	1	1
Connection Problem	1	1
Nonstandard Device	1	1
No Apparent Adverse Event	1	1
Material Separation	1	1
Difficult or Delayed Separation	1	1
Delivered as Unsterile Product	1	1
Problem with Sterilization	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	389	389
No Code Available	122	122
Pain	95	95
Insufficient Information	95	95
No Clinical Signs, Symptoms or Conditions	90	90
Unspecified Infection	82	82
Joint Laxity	58	58
No Patient Involvement	54	54
Failure of Implant	41	41
Fall	34	34
Ambulation Difficulties	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
No Known Impact Or Consequence To Patient	26	26
Injury	21	21
Foreign Body Reaction	16	16
Osteolysis	15	15
No Consequences Or Impact To Patient	15	15
Bone Fracture(s)	14	14
Loss of Range of Motion	12	12
No Information	12	12
Hematoma	11	11
Osteopenia/ Osteoporosis	9	9
Scar Tissue	7	7
Adhesion(s)	7	7
Inflammation	7	7
Unspecified Tissue Injury	6	6
Discomfort	6	6
Weakness	6	6
Ossification	6	6
Edema	6	6
Limited Mobility Of The Implanted Joint	6	6
Metal Related Pathology	6	6
Hemorrhage/Bleeding	5	5
Swelling/ Edema	5	5
Unspecified Musculoskeletal problem	4	4
Fatigue	4	4
Thrombosis	4	4
Hypersensitivity/Allergic reaction	4	4
Tissue Damage	4	4
Not Applicable	4	4
Muscle/Tendon Damage	4	4
Deformity/ Disfigurement	3	3
Test Result	3	3
Pulmonary Embolism	3	3
Necrosis	3	3
Rheumatoid Arthritis	3	3
Impaired Healing	3	3
Reaction	3	3
Anxiety	3	3
Limb Fracture	3	3