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
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	418	501
Fracture	192	248
Break	130	130
Loosening of Implant Not Related to Bone-Ingrowth	102	129
Appropriate Term/Code Not Available	66	66
Migration	32	32
Crack	26	26
Device Dislodged or Dislocated	25	25
Naturally Worn	22	22
Mechanical Jam	21	21
Device Appears to Trigger Rejection	20	20
Flaked	19	19
Unstable	18	18
Material Fragmentation	17	17
Connection Problem	16	16
Malposition of Device	15	15
Loss of Osseointegration	15	15
Difficult to Insert	15	15
Positioning Failure	14	14
Insufficient Information	13	13
Fitting Problem	12	12
Loose or Intermittent Connection	10	10
Loss of or Failure to Bond	10	10
Material Deformation	9	9
Failure to Osseointegrate	8	8
Noise, Audible	7	7
Material Twisted/Bent	7	7
Corroded	7	7
Degraded	7	7
Material Erosion	7	23
Device Damaged by Another Device	6	6
Material Protrusion/Extrusion	6	6
Defective Device	6	6
Detachment of Device or Device Component	5	5
Patient Device Interaction Problem	5	5
Separation Failure	5	5
Osseointegration Problem	4	60
Manufacturing, Packaging or Shipping Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Packaging Problem	3	3
Incomplete or Inadequate Connection	3	3
Migration or Expulsion of Device	3	3
Peeled/Delaminated	3	3
Use of Device Problem	3	3
Biocompatibility	2	2
Expiration Date Error	2	2
Microbial Contamination of Device	2	2
Improper or Incorrect Procedure or Method	2	2
Material Separation	2	2
Unsealed Device Packaging	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	314	314
Pain	296	352
Failure of Implant	121	121
Unspecified Infection	109	176
Insufficient Information	94	177
Bone Fracture(s)	68	68
No Known Impact Or Consequence To Patient	58	58
Inadequate Osseointegration	52	52
Joint Laxity	40	112
Swelling/ Edema	32	32
Loss of Range of Motion	28	28
Joint Dislocation	28	28
Device Embedded In Tissue or Plaque	25	25
Foreign Body In Patient	25	25
No Information	24	24
Implant Pain	21	21
Arthralgia	21	37
Swelling	19	19
Fall	18	18
No Patient Involvement	18	18
Arthritis	16	32
No Consequences Or Impact To Patient	16	16
Ambulation Difficulties	15	15
Osteolysis	15	31
Injury	15	15
Inflammation	12	12
Metal Related Pathology	11	11
Discomfort	10	10
Limited Mobility Of The Implanted Joint	9	9
Synovitis	9	9
No Code Available	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Numbness	8	8
Osteopenia/ Osteoporosis	7	7
Reaction	5	5
Damage to Ligament(s)	5	5
Cyst(s)	4	4
Joint Disorder	4	4
Unspecified Tissue Injury	4	4
Hematoma	3	59
Deformity/ Disfigurement	3	3
Joint Swelling	3	3
Patient Problem/Medical Problem	3	3
Scar Tissue	3	3
Embolism/Embolus	3	3
Hemorrhage/Bleeding	2	2
Erosion	2	2
Adhesion(s)	2	2
Wound Dehiscence	2	2
Necrosis	2	2