TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Regulation Description	Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Product Code	MBH
Regulation Number	888.3565
Device Class	2

Premarket Reviews
Manufacturer	Decision
CONFORMIS, INC.
	SUBSTANTIALLY EQUIVALENT	2
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	5
ENCORE MEDICAL L.P.
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, L.P. DBA DJO SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
LIMA CORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	3
MAXX ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	3
MEDISURGE, LLC
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
OPTIMOTION IMPLANTS, LLC
	SUBSTANTIALLY EQUIVALENT	2
ORTHO DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIGNAL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER BIOMET
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3212	3569
Fracture	1023	1283
Unstable	686	693
Loosening of Implant Not Related to Bone-Ingrowth	283	289
Insufficient Information	278	281
Loss of Osseointegration	261	261
Break	245	246
Detachment of Device or Device Component	225	229
Difficult to Insert	191	192
Osseointegration Problem	183	452
Migration	131	134
Naturally Worn	130	132
Degraded	116	116
Device Dislodged or Dislocated	114	116
Mechanical Problem	103	105
Malposition of Device	90	324
Positioning Failure	86	86
Noise, Audible	66	67
Loss of or Failure to Bond	65	68
Use of Device Problem	64	65
Patient Device Interaction Problem	54	57
Material Erosion	52	286
Material Deformation	50	50
Unintended Movement	46	46
Loose or Intermittent Connection	43	44
Connection Problem	40	40
Device Contaminated During Manufacture or Shipping	27	27
Crack	26	26
Inadequacy of Device Shape and/or Size	24	24
Appropriate Term/Code Not Available	24	26
Packaging Problem	23	23
Tear, Rip or Hole in Device Packaging	22	22
Failure to Osseointegrate	21	21
Component Missing	19	19
Mechanical Jam	18	18
Device Damaged Prior to Use	17	17
Incomplete or Inadequate Connection	16	16
Material Fragmentation	16	16
Corroded	15	15
Off-Label Use	15	16
Dull, Blunt	15	15
Improper or Incorrect Procedure or Method	12	12
Delivered as Unsterile Product	11	11
Contamination /Decontamination Problem	10	10
Shipping Damage or Problem	10	10
Material Twisted/Bent	10	10
Device Markings/Labelling Problem	9	9
Fitting Problem	9	9
Device Reprocessing Problem	8	8
Device-Device Incompatibility	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1827	1848
Pain	1811	2105
Joint Laxity	922	1190
Unspecified Infection	856	1127
Insufficient Information	755	1029
Loss of Range of Motion	689	794
Ambulation Difficulties	456	464
Inadequate Osseointegration	417	422
Swelling/ Edema	399	401
Failure of Implant	352	370
Scar Tissue	200	200
Bone Fracture(s)	175	177
Fall	169	172
Adhesion(s)	118	118
Joint Dislocation	82	317
Muscle/Tendon Damage	65	65
Discomfort	59	60
Thrombosis/Thrombus	59	59
Inflammation	58	59
Muscular Rigidity	54	55
Fibrosis	51	51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	51	51
Hypersensitivity/Allergic reaction	51	53
Osteolysis	49	285
Unspecified Tissue Injury	45	46
Synovitis	43	279
Damage to Ligament(s)	43	44
Fluid Discharge	36	38
Metal Related Pathology	36	270
Numbness	34	34
Implant Pain	27	27
Hematoma	25	26
Bacterial Infection	24	24
Wound Dehiscence	22	23
Foreign Body Reaction	22	23
Pulmonary Embolism	22	22
Impaired Healing	21	21
Erythema	21	21
Hemorrhage/Bleeding	19	19
Cyst(s)	19	20
Subluxation	19	20
Necrosis	18	19
Nerve Damage	18	19
Rupture	17	17
Limb Fracture	17	17
Cellulitis	16	16
Osteopenia/ Osteoporosis	15	16
Muscle Weakness	14	14
Embolism/Embolus	14	14
Ossification	14	14