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
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
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	398	717
Fracture	180	361
Loosening of Implant Not Related to Bone-Ingrowth	105	262
Break	77	77
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	17	17
Loss of Osseointegration	16	16
Unstable	15	15
Mechanical Jam	15	16
Malposition of Device	13	13
Fitting Problem	11	11
Material Fragmentation	11	11
Flaked	9	9
Insufficient Information	9	9
Material Deformation	9	9
Failure to Osseointegrate	9	9
Material Erosion	8	146
Loose or Intermittent Connection	8	8
Degraded	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	304	307
Pain	278	457
Failure of Implant	118	121
Insufficient Information	100	298
Unspecified Infection	89	284
Inadequate Osseointegration	56	56
Bone Fracture(s)	56	177
Joint Laxity	48	242
Swelling/ Edema	37	37
Joint Dislocation	29	30
Foreign Body In Patient	27	28
Loss of Range of Motion	27	27
Implant Pain	24	24
Arthralgia	23	40
Arthritis	23	39
Fall	18	18
Ambulation Difficulties	17	17
Osteolysis	16	154
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Device Embedded In Tissue or Plaque	15	15
Discomfort	10	10
Metal Related Pathology	9	131
Inflammation	7	7
Swelling	7	7
Damage to Ligament(s)	6	6
Cyst(s)	6	6
Synovitis	5	5
Unspecified Tissue Injury	5	5
Deformity/ Disfigurement	4	125
Osteopenia/ Osteoporosis	4	4
Hypersensitivity/Allergic reaction	3	3
Necrosis	3	124
Embolism/Embolus	3	3
Laceration(s)	3	3
Numbness	3	3
Erosion	2	2
Hemorrhage/Bleeding	2	2
Scar Tissue	2	2
Burning Sensation	2	2
Perforation	2	2
Adhesion(s)	2	2
Hematoma	2	58
Wound Dehiscence	2	2
Muscular Rigidity	1	1
Cellulitis	1	1
Post Operative Wound Infection	1	1
Ossification	1	1
Localized Skin Lesion	1	1
Muscle/Tendon Damage	1	1
Rupture	1	1