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	368	369
Appropriate Term/Code Not Available	57	57
Unstable	45	45
Loss of or Failure to Bond	28	28
Fracture	13	14
Difficult to Insert	11	11
Naturally Worn	9	9
Patient Device Interaction Problem	8	8
Device Contaminated During Manufacture or Shipping	7	7
Loosening of Implant Not Related to Bone-Ingrowth	7	8
Loose or Intermittent Connection	6	6
Device Dislodged or Dislocated	5	5
Use of Device Problem	4	4
Migration	4	4
Noise, Audible	4	4
Off-Label Use	3	3
Tear, Rip or Hole in Device Packaging	3	3
Break	2	2
Difficult to Open or Remove Packaging Material	2	2
Device Damaged Prior to Use	2	2
Material Erosion	2	3
Detachment of Device or Device Component	2	2
Mechanical Problem	1	1
Device Fell	1	1
Defective Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	2
Degraded	1	1
Material Too Rigid or Stiff	1	1
Inadequacy of Device Shape and/or Size	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	153	153
Joint Laxity	124	125
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	81	81
Unspecified Infection	65	66
Insufficient Information	52	52
Loss of Range of Motion	49	50
Adhesion(s)	40	40
Fall	27	27
Muscular Rigidity	25	25
No Clinical Signs, Symptoms or Conditions	24	24
Failure of Implant	21	24
Swelling/ Edema	17	17
Ambulation Difficulties	16	16
Synovitis	16	16
Implant Pain	10	11
Osteolysis	10	10
Scar Tissue	9	9
Inflammation	9	10
Bone Fracture(s)	8	8
Discomfort	8	8
Joint Dislocation	5	5
Wound Dehiscence	4	4
Muscle/Tendon Damage	4	4
Metal Related Pathology	4	4
Granuloma	3	3
Necrosis	3	3
Cyst(s)	3	3
Limb Fracture	2	2
Foreign Body Reaction	2	2
Hematoma	2	2
Hypersensitivity/Allergic reaction	2	2
Nerve Damage	1	1
Ossification	1	2
Myalgia	1	2
Rupture	1	1
Fatigue	1	1
Fluid Discharge	1	1
Arthralgia	1	1
Skin Infection	1	1
Unspecified Tissue Injury	1	1
Sleep Dysfunction	1	2
Joint Contracture	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1
Inadequate Pain Relief	1	2
Fibrosis	1	1
Impaired Healing	1	1
Retinal Tear	1	1
Damage to Ligament(s)	1	1