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	441	445
Adverse Event Without Identified Device or Use Problem	253	258
Fracture	90	95
Detachment of Device or Device Component	44	44
Naturally Worn	38	38
Unstable	31	31
Appropriate Term/Code Not Available	25	25
Difficult to Insert	23	24
Break	17	17
Off-Label Use	13	13
Loosening of Implant Not Related to Bone-Ingrowth	13	13
Insufficient Information	11	11
Scratched Material	11	11
Device Contaminated During Manufacture or Shipping	10	10
Material Deformation	9	9
Positioning Failure	9	9
Noise, Audible	8	9
Device-Device Incompatibility	7	7
Material Erosion	6	6
Mechanical Problem	5	5
Tear, Rip or Hole in Device Packaging	4	4
Difficult to Remove	4	4
Patient Device Interaction Problem	4	4
Migration	3	3
Device Difficult to Setup or Prepare	3	3
Contamination /Decontamination Problem	3	3
Unintended Movement	3	3
Degraded	2	2
Use of Device Problem	2	2
Component Missing	2	2
Packaging Problem	2	2
Illegible Information	2	2
Defective Device	2	2
Difficult to Open or Close	2	2
Improper or Incorrect Procedure or Method	2	2
Osseointegration Problem	2	6
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
No Apparent Adverse Event	1	1
Defective Component	1	1
Separation Failure	1	1
Malposition of Device	1	1
Deformation Due to Compressive Stress	1	1
Loss of Osseointegration	1	1
Biocompatibility	1	1
Incomplete or Missing Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	424	432
Insufficient Information	125	129
No Clinical Signs, Symptoms or Conditions	112	113
Unspecified Infection	88	93
Joint Laxity	81	83
Pain	71	76
Failure of Implant	41	42
Fall	33	33
Ambulation Difficulties	29	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	26	27
Bone Fracture(s)	14	14
Foreign Body Reaction	13	14
Osteolysis	11	11
Loss of Range of Motion	9	10
Scar Tissue	8	9
Unspecified Tissue Injury	6	7
Metal Related Pathology	6	6
Hematoma	6	6
Swelling/ Edema	5	5
Unspecified Musculoskeletal problem	5	5
Inflammation	5	5
Osteopenia/ Osteoporosis	5	5
Ossification	5	6
Deformity/ Disfigurement	4	4
Muscle/Tendon Damage	4	4
Necrosis	4	5
Discomfort	4	4
Physical Asymmetry	3	3
Limb Fracture	3	3
Unequal Limb Length	3	3
Anemia	3	3
Synovitis	3	3
Sepsis	3	3
Rheumatoid Arthritis	3	3
Impaired Healing	3	3
Implant Pain	2	2
Adhesion(s)	2	3
Fatigue	2	2
Subluxation	2	2
Hypersensitivity/Allergic reaction	2	2
Hemorrhage/Bleeding	2	2
Itching Sensation	1	1
Cardiac Arrest	1	1
Cyst(s)	1	1
Aspiration/Inhalation	1	1
Erythema	1	1
Muscular Rigidity	1	1
Nerve Damage	1	1
Numbness	1	1
Inadequate Osseointegration	1	1