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	2
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	2
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 BIOMET
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	453	771
Fracture	202	379
Break	132	132
Loosening of Implant Not Related to Bone-Ingrowth	116	272
Appropriate Term/Code Not Available	66	66
Migration	34	34
Device Dislodged or Dislocated	26	26
Crack	26	26
Naturally Worn	25	25
Device Appears to Trigger Rejection	24	24
Mechanical Jam	21	21
Unstable	19	19
Flaked	19	19
Positioning Failure	18	18
Loss of Osseointegration	17	17
Difficult to Insert	17	17
Material Fragmentation	17	17
Connection Problem	16	16
Malposition of Device	15	15
Insufficient Information	13	13
Fitting Problem	13	13
Loose or Intermittent Connection	10	10
Loss of or Failure to Bond	10	10
Material Deformation	9	9
Failure to Osseointegrate	9	9
Material Erosion	8	146
Degraded	8	8
Noise, Audible	7	7
Corroded	7	7
Device Damaged by Another Device	7	7
Material Twisted/Bent	7	7
Defective Device	6	6
Separation Failure	6	6
Material Protrusion/Extrusion	6	6
Patient Device Interaction Problem	6	6
Detachment of Device or Device Component	5	5
Improper or Incorrect Procedure or Method	4	125
Manufacturing, Packaging or Shipping Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Osseointegration Problem	4	60
Migration or Expulsion of Device	3	3
Packaging Problem	3	3
Use of Device Problem	3	3
Physical Resistance/Sticking	3	3
Incomplete or Inadequate Connection	3	3
Peeled/Delaminated	3	3
Positioning Problem	3	3
Dent in Material	2	2
Material Separation	2	2
Overheating of Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	326	326
Pain	324	501
Failure of Implant	126	126
Unspecified Infection	112	307
Insufficient Information	102	300
Bone Fracture(s)	72	193
No Known Impact Or Consequence To Patient	58	58
Inadequate Osseointegration	57	57
Joint Laxity	48	242
Swelling/ Edema	40	40
Joint Dislocation	28	28
Loss of Range of Motion	28	28
Foreign Body In Patient	27	27
Device Embedded In Tissue or Plaque	25	25
No Information	24	24
Arthritis	23	39
Arthralgia	23	40
Implant Pain	21	21
Osteolysis	19	157
Swelling	19	19
Fall	18	18
No Patient Involvement	18	18
Ambulation Difficulties	17	17
No Consequences Or Impact To Patient	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Injury	15	15
Inflammation	12	12
Metal Related Pathology	12	133
Discomfort	10	10
Synovitis	9	9
Limited Mobility Of The Implanted Joint	9	9
No Code Available	9	9
Numbness	8	8
Cyst(s)	7	7
Osteopenia/ Osteoporosis	7	7
Damage to Ligament(s)	6	6
Unspecified Tissue Injury	5	5
Reaction	5	5
Deformity/ Disfigurement	4	125
Joint Disorder	4	4
Patient Problem/Medical Problem	3	3
Scar Tissue	3	3
Joint Swelling	3	3
Necrosis	3	124
Embolism/Embolus	3	3
Hematoma	3	59
Muscular Rigidity	2	2
Burning Sensation	2	2
Adhesion(s)	2	2
Laceration(s)	2	2