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	438	442
Adverse Event Without Identified Device or Use Problem	263	267
Fracture	88	93
Detachment of Device or Device Component	45	45
Naturally Worn	38	38
Unstable	30	30
Difficult to Insert	25	26
Off-Label Use	13	13
Break	12	12
Loosening of Implant Not Related to Bone-Ingrowth	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
Insufficient Device Problem Information	8	8
Device-Device Incompatibility	7	7
Material Erosion	6	6
Mechanical Problem	5	5
Patient Device Interaction Problem	4	4
Tear, Rip or Hole in Device Packaging	4	4
Contamination /Decontamination Problem	3	3
Difficult to Remove	3	3
Device Difficult to Setup or Prepare	3	3
Unintended Movement	3	3
Migration	3	3
Degraded	2	2
Use of Device Problem	2	2
Component Missing	2	2
Defective Device	2	2
Packaging Problem	2	2
Illegible Information	2	2
Difficult to Open or Close	2	2
Improper or Incorrect Procedure or Method	2	2
Osseointegration Problem	2	6
Implant subsidence	1	1
Material Integrity Problem	1	1
Separation Failure	1	1
No Apparent Adverse Event	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Malposition of Device	1	1
Incomplete or Missing Packaging	1	1
Unintended System Motion	1	1
Deformation Due to Compressive Stress	1	1
Loss of Osseointegration	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	436	444
Insufficient Information	127	131
No Clinical Signs, Symptoms or Conditions	115	116
Unspecified Infection	91	96
Joint Laxity	85	87
Pain	74	79
Failure of Implant	41	42
Fall	33	33
Ambulation or Postural Difficulties	29	30
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	26	27
Bone Fracture(s)	14	14
Medical device site infection	13	13
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
Muscle/Tendon Damage	5	5
Inflammation	5	5
Osteopenia/ Osteoporosis	5	5
Extraskeletal ossification	5	6
Necrosis	4	5
Deformity/ Disfigurement	4	4
Aseptic loosening	4	8
Discomfort	4	4
Sepsis	3	3
Physical Asymmetry	3	3
Synovitis	3	3
Limb Fracture	3	3
Anemia	3	3
Rheumatoid Arthritis	3	3
Unequal Limb Length	3	3
Impaired Healing	3	3
Periprosthetic fracture	2	2
Subluxation	2	2
Joint Impingement	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Implant Pain	2	2
Adhesion(s)	2	3
Joint effusion	2	2
Fatigue	2	2
Hypersensitivity/Allergic reaction	2	2
Erythema	1	1
Muscular Rigidity	1	1
Nerve Damage	1	1
Numbness	1	1