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
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	380	380
Fracture	179	179
Break	130	130
Loosening of Implant Not Related to Bone-Ingrowth	89	89
Appropriate Term/Code Not Available	64	64
Migration	31	31
Crack	26	26
Device Dislodged or Dislocated	24	24
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	13	13
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
Positioning Failure	7	7
Device Damaged by Another Device	6	6
Material Protrusion/Extrusion	6	6
Patient Device Interaction Problem	5	5
Degraded	5	5
Defective Device	5	5
Detachment of Device or Device Component	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Separation Failure	4	4
Material Erosion	4	4
Use of Device Problem	3	3
Osseointegration Problem	3	3
Migration or Expulsion of Device	3	3
Packaging Problem	3	3
Peeled/Delaminated	3	3
Incomplete or Inadequate Connection	3	3
Biocompatibility	2	2
Microbial Contamination of Device	2	2
Positioning Problem	2	2
Mechanical Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Physical Resistance/Sticking	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	301	301
Pain	273	273
Failure of Implant	118	118
Unspecified Infection	103	103
Insufficient Information	84	84
Bone Fracture(s)	66	66
No Known Impact Or Consequence To Patient	58	58
Inadequate Osseointegration	50	50
Joint Laxity	36	36
Swelling/ Edema	28	28
Joint Dislocation	27	27
Loss of Range of Motion	27	27
Foreign Body In Patient	24	24
No Information	24	24
Device Embedded In Tissue or Plaque	23	23
Implant Pain	21	21
Swelling	19	19
Arthralgia	18	18
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
Inflammation	12	12
Arthritis	12	12
Metal Related Pathology	11	11
Discomfort	10	10
Synovitis	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
No Code Available	9	9
Limited Mobility Of The Implanted Joint	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
Embolism/Embolus	3	3
Deformity/ Disfigurement	3	3
Patient Problem/Medical Problem	3	3
Scar Tissue	3	3
Joint Swelling	3	3
Hemorrhage/Bleeding	2	2
Erosion	2	2
Laceration(s)	2	2
Muscular Rigidity	2	2
Necrosis	2	2
Adhesion(s)	2	2