TPLC - Total Product Life Cycle

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Device	prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
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	378	378
Appropriate Term/Code Not Available	97	97
Unstable	59	59
Fracture	41	41
Loss of or Failure to Bond	31	31
Insufficient Information	19	19
Difficult to Insert	13	13
Naturally Worn	13	13
Loosening of Implant Not Related to Bone-Ingrowth	11	11
Noise, Audible	11	11
Loose or Intermittent Connection	10	10
Device Contaminated During Manufacture or Shipping	8	8
Migration	7	7
Device Dislodged or Dislocated	7	7
Patient Device Interaction Problem	6	6
Use of Device Problem	4	4
Tear, Rip or Hole in Device Packaging	4	4
Detachment of Device or Device Component	4	4
Inadequacy of Device Shape and/or Size	4	4
Break	4	4
Off-Label Use	4	4
Device Damaged Prior to Use	3	3
Material Erosion	2	2
Patient-Device Incompatibility	2	2
Difficult or Delayed Positioning	2	2
Packaging Problem	2	2
Difficult to Open or Remove Packaging Material	2	2
Defective Device	2	2
Device Fell	1	1
Material Too Rigid or Stiff	1	1
Positioning Failure	1	1
Degraded	1	1
Excessive Cooling	1	1
Migration or Expulsion of Device	1	1
Incomplete or Inadequate Connection	1	1
Mechanical Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	193	193
Joint Laxity	104	104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	84	84
Unspecified Infection	82	82
Insufficient Information	58	58
Loss of Range of Motion	57	57
Adhesion(s)	45	45
Fall	33	33
No Code Available	33	33
Muscular Rigidity	33	33
Failure of Implant	32	32
No Known Impact Or Consequence To Patient	29	29
No Clinical Signs, Symptoms or Conditions	24	24
Synovitis	20	20
Ambulation Difficulties	19	19
Swelling/ Edema	19	19
Limited Mobility Of The Implanted Joint	19	19
No Information	17	17
Osteolysis	13	13
Swelling	12	12
Discomfort	11	11
Inflammation	11	11
Scar Tissue	10	10
No Patient Involvement	8	8
Bone Fracture(s)	7	7
Joint Dislocation	6	6
Implant Pain	6	6
Cancer	5	5
No Consequences Or Impact To Patient	5	5
Wound Dehiscence	5	5
Metal Related Pathology	5	5
Necrosis	5	5
Ossification	4	4
Cyst(s)	4	4
Hypersensitivity/Allergic reaction	4	4
Edema	3	3
Hematoma	3	3
Reaction	3	3
Muscle/Tendon Damage	3	3
Embolism	3	3
Granuloma	3	3
Foreign Body Reaction	2	2
Injury	2	2
Limb Fracture	2	2
Weight Changes	2	2
Myalgia	1	1
Rupture	1	1
Weakness	1	1
Thrombosis/Thrombus	1	1
Abrasion	1	1