TPLC - Total Product Life Cycle

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Device	prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
Regulation Description	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Definition	Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.
Product Code	OIY
Regulation Number	888.3560
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	375	375
Appropriate Term/Code Not Available	78	78
Unstable	53	53
Loss of or Failure to Bond	31	31
Fracture	30	30
Difficult to Insert	13	13
Naturally Worn	12	12
Loosening of Implant Not Related to Bone-Ingrowth	11	11
Noise, Audible	8	8
Device Contaminated During Manufacture or Shipping	7	7
Migration	7	7
Loose or Intermittent Connection	7	7
Patient Device Interaction Problem	6	6
Device Dislodged or Dislocated	6	6
Insufficient Information	5	5
Break	4	4
Off-Label Use	4	4
Use of Device Problem	4	4
Device Damaged Prior to Use	3	3
Tear, Rip or Hole in Device Packaging	3	3
Detachment of Device or Device Component	3	3
Difficult to Open or Remove Packaging Material	2	2
Material Erosion	2	2
Inadequacy of Device Shape and/or Size	2	2
Mechanical Problem	1	1
Excessive Cooling	1	1
Patient-Device Incompatibility	1	1
Device Fell	1	1
Defective Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Degraded	1	1
Positioning Failure	1	1
Material Too Rigid or Stiff	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	176	176
Joint Laxity	109	109
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	84	84
Unspecified Infection	75	75
Insufficient Information	58	58
Loss of Range of Motion	55	55
Adhesion(s)	45	45
Fall	33	33
Muscular Rigidity	31	31
Failure of Implant	26	26
No Code Available	25	25
No Clinical Signs, Symptoms or Conditions	24	24
Ambulation Difficulties	19	19
Swelling/ Edema	18	18
No Known Impact Or Consequence To Patient	18	18
Synovitis	18	18
Osteolysis	13	13
Limited Mobility Of The Implanted Joint	12	12
Inflammation	11	11
Discomfort	10	10
Scar Tissue	9	9
Swelling	9	9
Bone Fracture(s)	6	6
Implant Pain	6	6
No Patient Involvement	6	6
Joint Dislocation	6	6
No Information	5	5
Wound Dehiscence	5	5
Cyst(s)	4	4
Necrosis	4	4
Ossification	4	4
Metal Related Pathology	4	4
Hypersensitivity/Allergic reaction	4	4
Hematoma	3	3
Granuloma	3	3
Edema	3	3
Muscle/Tendon Damage	3	3
No Consequences Or Impact To Patient	2	2
Limb Fracture	2	2
Reaction	2	2
Foreign Body Reaction	2	2
Nerve Damage	1	1
Syncope	1	1
Arthralgia	1	1
Thrombosis/Thrombus	1	1
Fatigue	1	1
Myalgia	1	1
Fluid Discharge	1	1
Sleep Dysfunction	1	1
Impaired Healing	1	1