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	495	499
Adverse Event Without Identified Device or Use Problem	273	279
Fracture	101	107
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	29
Unstable	28	28
Insufficient Information	20	20
Break	15	16
Packaging Problem	15	15
Loosening of Implant Not Related to Bone-Ingrowth	12	12
Noise, Audible	12	13
Off-Label Use	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
Tear, Rip or Hole in Device Packaging	6	6
Migration	6	6
Mechanical Problem	5	5
Contamination /Decontamination Problem	4	4
Patient Device Interaction Problem	4	5
Difficult to Remove	4	4
Separation Failure	3	3
Device Difficult to Setup or Prepare	3	3
Use of Device Problem	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Osseointegration Problem	2	6
Inadequacy of Device Shape and/or Size	2	2
Deformation Due to Compressive Stress	2	2
Defective Device	2	2
Illegible Information	2	2
Malposition of Device	2	2
Difficult to Open or Close	2	2
Improper or Incorrect Procedure or Method	2	2
Degraded	2	2
Mechanical Jam	1	1
Material Twisted/Bent	1	1
Nonstandard Device	1	1
Delivered as Unsterile Product	1	1
Physical Resistance/Sticking	1	1
Defective Component	1	1
Loose or Intermittent Connection	1	1
Difficult or Delayed Separation	1	1
Material Separation	1	1
Problem with Sterilization	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	466	475
No Code Available	122	124
Insufficient Information	117	121
Pain	104	110
No Clinical Signs, Symptoms or Conditions	100	101
Unspecified Infection	100	106
Joint Laxity	74	76
No Patient Involvement	54	54
Failure of Implant	44	45
Fall	38	38
Ambulation Difficulties	34	35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	28
No Known Impact Or Consequence To Patient	26	26
Injury	21	21
Foreign Body Reaction	17	18
Osteolysis	17	17
No Consequences Or Impact To Patient	15	15
Bone Fracture(s)	15	16
No Information	12	12
Loss of Range of Motion	12	13
Hematoma	11	11
Scar Tissue	9	10
Osteopenia/ Osteoporosis	9	9
Metal Related Pathology	8	9
Inflammation	7	7
Adhesion(s)	7	8
Limited Mobility Of The Implanted Joint	6	6
Unspecified Tissue Injury	6	7
Discomfort	6	6
Ossification	6	7
Edema	6	6
Weakness	6	6
Hemorrhage/Bleeding	5	6
Unspecified Musculoskeletal problem	5	5
Swelling/ Edema	5	5
Necrosis	5	6
Thrombosis	4	4
Hypersensitivity/Allergic reaction	4	4
Muscle/Tendon Damage	4	4
Tissue Damage	4	4
Deformity/ Disfigurement	4	4
Not Applicable	4	4
Fatigue	4	4
Unequal Limb Length	3	3
Pulmonary Embolism	3	3
Reaction	3	3
Rheumatoid Arthritis	3	3
Limb Fracture	3	3
Anxiety	3	3
Test Result	3	3