TPLC - Total Product Life Cycle

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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	1
CONFORMIS INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	6
1. K202194 ATTUNE® Porous Fixed Bearing Tibial Base, Medializ ...
2. K212746 ATTUNE Revision Cones
3. K213781 ATTUNE® Porous Fixed Bearing Tibial Base with AFFI ...
4. K230295 ATTUNE® Revision Cones
5. K232303 ATTUNE® Porous Fixed Bearing Tibial Base, Medializ ...
6. K240678 ATTUNE® Porous Fixed Bearing Tibial Base, Medializ ...
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.
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	3
MAXX ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDISURGE, LLC
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	2
OPTIMOTION IMPLANTS LLC
	SUBSTANTIALLY EQUIVALENT	1
OPTIMOTION IMPLANTS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SIGNAL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
UNIK ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER BIOMET
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2544	2544
Fracture	884	884
Unstable	743	743
Insufficient Information	549	549
Loss of Osseointegration	311	311
Break	310	310
Loosening of Implant Not Related to Bone-Ingrowth	187	187
Detachment of Device or Device Component	182	182
Difficult to Insert	178	178
Naturally Worn	144	144
Osseointegration Problem	133	133
Migration	118	118
Device Dislodged or Dislocated	112	112
Degraded	101	101
Mechanical Problem	76	76
Noise, Audible	74	74
Malposition of Device	72	72
Positioning Failure	59	59
Loss of or Failure to Bond	52	52
Material Erosion	51	51
Use of Device Problem	50	50
Unintended Movement	48	48
Loose or Intermittent Connection	47	47
Patient Device Interaction Problem	47	47
Connection Problem	46	46
Material Deformation	44	44
Appropriate Term/Code Not Available	38	38
Crack	29	29
Dull, Blunt	29	29
Mechanical Jam	22	22
Inadequacy of Device Shape and/or Size	21	21
Component Missing	20	20
Packaging Problem	19	19
Incomplete or Inadequate Connection	17	17
Device Contaminated During Manufacture or Shipping	17	17
Corroded	16	16
Off-Label Use	16	16
Tear, Rip or Hole in Device Packaging	15	15
Device-Device Incompatibility	14	14
Device Damaged Prior to Use	13	13
Material Fragmentation	13	13
Failure to Osseointegrate	13	13
Device Difficult to Setup or Prepare	12	12
Contamination /Decontamination Problem	10	10
Fitting Problem	10	10
Device Markings/Labelling Problem	8	8
Device Reprocessing Problem	8	8
Defective Device	8	8
Improper or Incorrect Procedure or Method	8	8
Material Integrity Problem	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	1623	1623
No Clinical Signs, Symptoms or Conditions	1476	1476
Unspecified Infection	747	747
Joint Laxity	665	665
Insufficient Information	596	596
Loss of Range of Motion	577	577
Ambulation Difficulties	434	434
Inadequate Osseointegration	379	379
Injury	350	350
Failure of Implant	321	321
Swelling/ Edema	320	320
Scar Tissue	208	208
Bone Fracture(s)	179	179
Fall	169	169
Adhesion(s)	125	125
No Known Impact Or Consequence To Patient	110	110
No Patient Involvement	88	88
Inflammation	78	78
No Consequences Or Impact To Patient	76	76
Joint Dislocation	71	71
Muscular Rigidity	68	68
Thrombosis/Thrombus	54	54
Discomfort	53	53
Muscle/Tendon Damage	52	52
No Information	52	52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	50	50
Fibrosis	43	43
Osteolysis	41	41
Unspecified Tissue Injury	41	41
Limited Mobility Of The Implanted Joint	38	38
Swelling	38	38
Damage to Ligament(s)	35	35
Hypersensitivity/Allergic reaction	34	34
Synovitis	33	33
Bacterial Infection	32	32
Numbness	28	28
Hematoma	26	26
Wound Dehiscence	24	24
Impaired Healing	21	21
Nerve Damage	21	21
Foreign Body Reaction	21	21
Fluid Discharge	20	20
Aspiration/Inhalation	20	20
Implant Pain	20	20
No Code Available	19	19
Necrosis	19	19
Cyst(s)	19	19
Embolism	19	19
Metal Related Pathology	18	18
Subluxation	17	17