TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BODYCAD LABORATORIES INC.
	SUBSTANTIALLY EQUIVALENT	1
BODYCAD LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	6
CONFORMIS, INC.
	SUBSTANTIALLY EQUIVALENT	4
CONSENSUS ORTHOPEDICS, INC
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
IMPLANTCAST GMBH
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
MATERIALISE N.V.
	SUBSTANTIALLY EQUIVALENT	1
MATERIALISE NV
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	3
ORTHO DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OVERTURE RESURFACING INC.
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW INC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	7
TORNIER, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	469	469
Fracture	221	221
Insufficient Information	192	192
Break	172	172
Loosening of Implant Not Related to Bone-Ingrowth	105	105
Appropriate Term/Code Not Available	99	99
Loose or Intermittent Connection	45	45
Device Dislodged or Dislocated	40	40
Migration	37	37
Naturally Worn	37	37
Unstable	36	36
Migration or Expulsion of Device	29	29
Crack	29	29
Difficult to Insert	26	26
Malposition of Device	24	24
Mechanical Jam	22	22
Failure To Adhere Or Bond	18	18
Device Appears to Trigger Rejection	18	18
Fitting Problem	18	18
Loss of Osseointegration	17	17
Material Fragmentation	16	16
Flaked	16	16
Connection Problem	16	16
Device Slipped	16	16
Device Contamination with Chemical or Other Material	15	15
Loss of or Failure to Bond	13	13
Noise, Audible	12	12
Material Deformation	11	11
Device Operates Differently Than Expected	10	10
Positioning Failure	9	9
Material Twisted/Bent	9	9
Degraded	9	9
Failure to Osseointegrate	8	8
Packaging Problem	7	7
Corroded	7	7
Mechanical Problem	6	6
Nonstandard Device	6	6
Detachment of Device or Device Component	6	6
No Apparent Adverse Event	6	6
Inadequacy of Device Shape and/or Size	6	6
Material Protrusion/Extrusion	6	6
Patient Device Interaction Problem	5	5
Defective Device	5	5
Physical Resistance/Sticking	5	5
Device Damaged by Another Device	5	5
Peeled/Delaminated	4	4
Material Erosion	4	4
Component Missing	4	4
Positioning Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	464	464
No Clinical Signs, Symptoms or Conditions	288	288
Unspecified Infection	152	152
Failure of Implant	135	135
No Known Impact Or Consequence To Patient	126	126
No Information	110	110
Injury	104	104
Bone Fracture(s)	102	102
No Code Available	90	90
Insufficient Information	80	80
Swelling	53	53
Inadequate Osseointegration	48	48
No Consequences Or Impact To Patient	46	46
Loss of Range of Motion	42	42
Joint Laxity	32	32
Joint Dislocation	32	32
Ambulation Difficulties	31	31
Fall	30	30
Limited Mobility Of The Implanted Joint	29	29
Foreign Body In Patient	29	29
Swelling/ Edema	28	28
Arthralgia	25	25
Device Embedded In Tissue or Plaque	24	24
No Patient Involvement	21	21
Osteolysis	20	20
Discomfort	16	16
Arthritis	15	15
Implant Pain	15	15
Patient Problem/Medical Problem	15	15
Inflammation	14	14
Synovitis	12	12
Metal Related Pathology	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Joint Disorder	8	8
Necrosis	8	8
Cyst(s)	8	8
Osteopenia/ Osteoporosis	8	8
Numbness	8	8
Damage to Ligament(s)	6	6
Reaction	5	5
Wound Dehiscence	4	4
Tissue Damage	4	4
Unspecified Tissue Injury	4	4
Joint Swelling	4	4
Deformity/ Disfigurement	3	3
Hemorrhage/Bleeding	3	3
Embolism/Embolus	3	3
Complaint, Ill-Defined	3	3
Toxicity	3	3
Abscess	3	3