TPLC - Total Product Life Cycle

show TPLC since

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
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTCAST GMBH
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
MATERIALISE NV
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OVERTURE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
OVERTURE RESURFACING INC.
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	400	400
Fracture	184	184
Break	130	130
Loosening of Implant Not Related to Bone-Ingrowth	94	94
Appropriate Term/Code Not Available	66	66
Migration	31	31
Crack	26	26
Device Dislodged or Dislocated	25	25
Naturally Worn	22	22
Mechanical Jam	21	21
Flaked	19	19
Device Appears to Trigger Rejection	19	19
Unstable	18	18
Material Fragmentation	17	17
Connection Problem	16	16
Loss of Osseointegration	15	15
Malposition of Device	15	15
Difficult to Insert	14	14
Positioning Failure	14	14
Fitting Problem	12	12
Loss of or Failure to Bond	10	10
Loose or Intermittent Connection	10	10
Insufficient Information	10	10
Material Deformation	9	9
Failure to Osseointegrate	8	8
Noise, Audible	7	7
Corroded	7	7
Material Twisted/Bent	7	7
Defective Device	6	6
Material Protrusion/Extrusion	6	6
Device Damaged by Another Device	6	6
Separation Failure	5	5
Detachment of Device or Device Component	5	5
Patient Device Interaction Problem	5	5
Degraded	5	5
Material Erosion	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Osseointegration Problem	3	3
Packaging Problem	3	3
Use of Device Problem	3	3
Peeled/Delaminated	3	3
Incomplete or Inadequate Connection	3	3
Migration or Expulsion of Device	3	3
Material Separation	2	2
Microbial Contamination of Device	2	2
Positioning Problem	2	2
No Apparent Adverse Event	2	2
Expiration Date Error	2	2
Unsealed Device Packaging	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	309	309
Pain	281	281
Failure of Implant	119	119
Unspecified Infection	106	106
Insufficient Information	85	85
Bone Fracture(s)	68	68
No Known Impact Or Consequence To Patient	58	58
Inadequate Osseointegration	52	52
Joint Laxity	37	37
Swelling/ Edema	32	32
Joint Dislocation	28	28
Loss of Range of Motion	28	28
Foreign Body In Patient	24	24
No Information	24	24
Device Embedded In Tissue or Plaque	23	23
Implant Pain	21	21
Arthralgia	20	20
Swelling	19	19
Fall	18	18
No Patient Involvement	18	18
No Consequences Or Impact To Patient	16	16
Ambulation Difficulties	15	15
Injury	15	15
Osteolysis	14	14
Arthritis	13	13
Inflammation	12	12
Metal Related Pathology	11	11
Discomfort	10	10
Synovitis	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Limited Mobility Of The Implanted Joint	9	9
No Code Available	9	9
Numbness	8	8
Osteopenia/ Osteoporosis	7	7
Damage to Ligament(s)	5	5
Reaction	5	5
Cyst(s)	4	4
Unspecified Tissue Injury	4	4
Joint Disorder	4	4
Deformity/ Disfigurement	3	3
Patient Problem/Medical Problem	3	3
Scar Tissue	3	3
Joint Swelling	3	3
Embolism/Embolus	3	3
Muscular Rigidity	2	2
Necrosis	2	2
Laceration(s)	2	2
Wound Dehiscence	2	2
Erosion	2	2
Hemorrhage/Bleeding	2	2