TPLC - Total Product Life Cycle

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Device	prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Regulation Description	Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Product Code	HSX
Regulation Number	888.3520
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
BODYCAD LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K241260 ACTIFY™ Unicondylar Knee System
IMPLANTCAST GMBH
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
ORTHO DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OVERTURE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
OVERTURE RESURFACING, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHALBY ADVANCED TECHNOLOGIES, INC. DBA CONSENSUS ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	2
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER BIOMET
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	399	718
Fracture	182	363
Loosening of Implant Not Related to Bone-Ingrowth	106	263
Break	79	79
Appropriate Term/Code Not Available	48	48
Migration	30	30
Device Appears to Trigger Rejection	26	26
Device Dislodged or Dislocated	26	27
Naturally Worn	22	22
Crack	20	20
Difficult to Insert	19	19
Positioning Failure	18	18
Loss of Osseointegration	16	16
Unstable	15	15
Mechanical Jam	15	16
Malposition of Device	13	13
Material Fragmentation	12	12
Fitting Problem	11	11
Degraded	11	11
Insufficient Information	10	10
Flaked	9	9
Material Deformation	9	9
Failure to Osseointegrate	9	9
Material Erosion	8	146
Loose or Intermittent Connection	8	8
Material Twisted/Bent	8	8
Noise, Audible	7	7
Corroded	7	7
Separation Failure	6	6
Connection Problem	5	5
Detachment of Device or Device Component	5	5
Device Damaged by Another Device	5	5
Loss of or Failure to Bond	4	4
Osseointegration Problem	4	60
Improper or Incorrect Procedure or Method	4	125
Defective Device	4	4
Patient Device Interaction Problem	4	4
Inadequacy of Device Shape and/or Size	3	3
Use of Device Problem	3	3
Peeled/Delaminated	3	3
Incomplete or Inadequate Connection	3	3
Physical Resistance/Sticking	3	3
Migration or Expulsion of Device	3	3
Packaging Problem	2	2
Premature Separation	2	2
Positioning Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Unsealed Device Packaging	2	2
No Apparent Adverse Event	2	2
Biocompatibility	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	308	311
Pain	283	462
Failure of Implant	118	121
Insufficient Information	102	300
Unspecified Infection	89	284
Inadequate Osseointegration	56	56
Bone Fracture(s)	56	177
Joint Laxity	49	243
Swelling/ Edema	38	38
Joint Dislocation	29	30
Loss of Range of Motion	27	27
Foreign Body In Patient	27	28
Implant Pain	24	24
Arthritis	23	39
Arthralgia	23	40
Fall	18	18
Ambulation Difficulties	17	17
Osteolysis	16	154
Device Embedded In Tissue or Plaque	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Metal Related Pathology	12	134
Discomfort	11	11
Damage to Ligament(s)	7	7
Inflammation	7	7
Swelling	7	7
Cyst(s)	6	6
Unspecified Tissue Injury	5	5
Synovitis	5	5
Osteopenia/ Osteoporosis	4	4
Deformity/ Disfigurement	4	125
Embolism/Embolus	3	3
Numbness	3	3
Laceration(s)	3	3
Necrosis	3	124
Hypersensitivity/Allergic reaction	3	3
Burning Sensation	2	2
Perforation	2	2
Hematoma	2	58
Adhesion(s)	2	2
Scar Tissue	2	2
Erosion	2	2
Hemorrhage/Bleeding	2	2
Wound Dehiscence	2	2
Localized Skin Lesion	1	1
Ossification	1	1
Cellulitis	1	1
Post Operative Wound Infection	1	1
Rupture	1	1
Muscular Rigidity	1	1
Skin Inflammation/ Irritation	1	1