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	396	396
Appropriate Term/Code Not Available	78	78
Unstable	64	64
Fracture	31	31
Loss of or Failure to Bond	31	31
Loosening of Implant Not Related to Bone-Ingrowth	13	14
Difficult to Insert	13	13
Naturally Worn	13	13
Noise, Audible	8	8
Device Contaminated During Manufacture or Shipping	7	7
Migration	7	7
Device Dislodged or Dislocated	7	7
Loose or Intermittent Connection	7	7
Patient Device Interaction Problem	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
Inadequacy of Device Shape and/or Size	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
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	179	179
Joint Laxity	123	124
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	82	82
Unspecified Infection	80	80
Insufficient Information	59	59
Loss of Range of Motion	57	58
Adhesion(s)	45	45
Fall	34	34
Muscular Rigidity	31	31
Failure of Implant	27	28
No Code Available	25	25
No Clinical Signs, Symptoms or Conditions	24	24
Ambulation Difficulties	19	19
Swelling/ Edema	19	19
Synovitis	19	19
No Known Impact Or Consequence To Patient	18	18
Osteolysis	13	13
Limited Mobility Of The Implanted Joint	12	12
Inflammation	11	12
Scar Tissue	10	10
Discomfort	10	10
Implant Pain	10	11
Swelling	9	9
Joint Dislocation	7	7
Bone Fracture(s)	7	7
No Patient Involvement	6	6
No Information	5	5
Metal Related Pathology	5	5
Wound Dehiscence	5	5
Ossification	4	4
Cyst(s)	4	4
Necrosis	4	4
Hypersensitivity/Allergic reaction	4	4
Muscle/Tendon Damage	4	4
Edema	3	3
Hematoma	3	3
Granuloma	3	3
Foreign Body Reaction	2	2
Reaction	2	2
Limb Fracture	2	2
No Consequences Or Impact To Patient	2	2
Myalgia	1	2
Rupture	1	1
Sepsis	1	1
Fatigue	1	1
Arthralgia	1	1
Nerve Damage	1	1
Syncope	1	1
Fluid Discharge	1	1
Impaired Healing	1	1