TPLC - Total Product Life Cycle

• Device: prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer
• Product Code: MBV
• Regulation Number: 888.3560
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	16	16
2020	10	10
2021	1	1
2022	6	6
2023	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9	9
Loosening of Implant Not Related to Bone-Ingrowth	6	6
Loss of or Failure to Bond	6	6
Fracture	4	4
Insufficient Information	3	3
Detachment of Device or Device Component	2	2
Noise, Audible	2	2
Degraded	2	2
Unstable	2	2
Incomplete or Missing Packaging	1	1
Tear, Rip or Hole in Device Packaging	1	1
Malposition of Device	1	1
Material Erosion	1	1
Delivered as Unsterile Product	1	1
Migration	1	1
Appropriate Term/Code Not Available	1	1
Osseointegration Problem	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	17	17
Limited Mobility Of The Implanted Joint	9	9
No Information	4	4
Insufficient Information	4	4
Swelling	4	4
Failure of Implant	4	4
Metal Related Pathology	3	3
Ambulation Difficulties	3	3
Bone Fracture(s)	3	3
Osteopenia/ Osteoporosis	2	2
No Patient Involvement	2	2
Swelling/ Edema	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Erosion	2	2
Synovitis	2	2
Discomfort	1	1
Reaction	1	1
Loss of Range of Motion	1	1
Local Reaction	1	1
Sepsis	1	1
Fall	1	1
Ossification	1	1
Adhesion(s)	1	1
Unspecified Infection	1	1
Muscle Weakness	1	1
Muscular Rigidity	1	1
Inadequate Osseointegration	1	1
No Code Available	1	1
No Known Impact Or Consequence To Patient	1	1