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	413	413
Adverse Event Without Identified Device or Use Problem	215	215
Fracture	90	90
Device Contaminated During Manufacture or Shipping	68	68
Naturally Worn	52	52
Detachment of Device or Device Component	42	42
Appropriate Term/Code Not Available	30	30
Difficult to Insert	21	21
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
Manufacturing, Packaging or Shipping Problem	2	2
Deformation Due to Compressive Stress	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
Improper or Incorrect Procedure or Method	1	1
Loss of or Failure to Bond	1	1
Loss of Osseointegration	1	1
Loose or Intermittent Connection	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	378	378
No Code Available	122	122
Pain	95	95
Insufficient Information	94	94
No Clinical Signs, Symptoms or Conditions	89	89
Unspecified Infection	80	80
Joint Laxity	55	55
No Patient Involvement	54	54
Failure of Implant	41	41
Fall	34	34
Ambulation Difficulties	30	30
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
No Consequences Or Impact To Patient	15	15
Osteolysis	15	15
Bone Fracture(s)	14	14
No Information	12	12
Loss of Range of Motion	12	12
Hematoma	11	11
Osteopenia/ Osteoporosis	9	9
Inflammation	7	7
Adhesion(s)	7	7
Scar Tissue	7	7
Limited Mobility Of The Implanted Joint	6	6
Metal Related Pathology	6	6
Unspecified Tissue Injury	6	6
Edema	6	6
Ossification	6	6
Weakness	6	6
Discomfort	6	6
Swelling/ Edema	5	5
Hemorrhage/Bleeding	5	5
Tissue Damage	4	4
Fatigue	4	4
Not Applicable	4	4
Unspecified Musculoskeletal problem	4	4
Muscle/Tendon Damage	4	4
Hypersensitivity/Allergic reaction	4	4
Thrombosis	4	4
Test Result	3	3
Necrosis	3	3
Anxiety	3	3
Reaction	3	3
Rheumatoid Arthritis	3	3
Deformity/ Disfigurement	3	3
Impaired Healing	3	3
Pulmonary Embolism	3	3
Physical Asymmetry	2	2