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	2
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	6
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
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
LIMA CORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	4
MAXX ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDISURGE, LLC
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
OPTIMOTION IMPLANTS, LLC
	SUBSTANTIALLY EQUIVALENT	3
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
UNIK ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
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	3215	3574
Fracture	1058	1318
Unstable	833	842
Insufficient Information	588	591
Loss of Osseointegration	345	345
Break	319	320
Loosening of Implant Not Related to Bone-Ingrowth	269	275
Detachment of Device or Device Component	234	238
Difficult to Insert	205	206
Osseointegration Problem	182	451
Naturally Worn	156	158
Migration	141	144
Device Dislodged or Dislocated	122	124
Degraded	117	117
Mechanical Problem	104	106
Malposition of Device	96	330
Positioning Failure	93	93
Noise, Audible	78	79
Loss of or Failure to Bond	70	73
Use of Device Problem	61	62
Material Erosion	58	292
Patient Device Interaction Problem	54	57
Unintended Movement	53	53
Material Deformation	52	52
Loose or Intermittent Connection	47	48
Connection Problem	46	46
Appropriate Term/Code Not Available	38	41
Crack	29	29
Dull, Blunt	29	29
Device Contaminated During Manufacture or Shipping	27	27
Inadequacy of Device Shape and/or Size	26	26
Mechanical Jam	23	23
Failure to Osseointegrate	23	23
Component Missing	22	22
Packaging Problem	22	22
Tear, Rip or Hole in Device Packaging	21	21
Device Damaged Prior to Use	17	17
Incomplete or Inadequate Connection	17	17
Corroded	16	16
Device-Device Incompatibility	16	16
Off-Label Use	16	17
Improper or Incorrect Procedure or Method	15	15
Material Fragmentation	15	15
Device Difficult to Setup or Prepare	12	12
Fitting Problem	10	10
Contamination /Decontamination Problem	10	10
Material Twisted/Bent	10	10
Defective Device	9	9
Device Markings/Labelling Problem	9	9
Manufacturing, Packaging or Shipping Problem	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	1971	2266
No Clinical Signs, Symptoms or Conditions	1765	1786
Unspecified Infection	918	1191
Joint Laxity	902	1170
Insufficient Information	760	1034
Loss of Range of Motion	704	811
Ambulation Difficulties	508	515
Inadequate Osseointegration	464	469
Swelling/ Edema	406	410
Failure of Implant	362	380
Injury	350	350
Scar Tissue	225	225
Fall	198	201
Bone Fracture(s)	197	199
Adhesion(s)	127	127
No Known Impact Or Consequence To Patient	110	110
No Patient Involvement	88	88
Joint Dislocation	85	320
Inflammation	80	81
No Consequences Or Impact To Patient	76	76
Muscular Rigidity	74	75
Muscle/Tendon Damage	64	64
Discomfort	63	63
Thrombosis/Thrombus	59	59
Fibrosis	52	52
No Information	52	55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	51	51
Hypersensitivity/Allergic reaction	50	52
Osteolysis	50	285
Damage to Ligament(s)	46	47
Unspecified Tissue Injury	43	43
Synovitis	43	279
Limited Mobility Of The Implanted Joint	38	38
Swelling	38	40
Numbness	36	36
Metal Related Pathology	35	269
Bacterial Infection	35	35
Hematoma	30	31
Fluid Discharge	29	31
Implant Pain	28	28
Wound Dehiscence	28	29
Pulmonary Embolism	24	24
Foreign Body Reaction	22	23
Impaired Healing	22	22
Subluxation	21	22
Nerve Damage	21	22
Aspiration/Inhalation	20	20
Cellulitis	20	22
Limb Fracture	19	19
Necrosis	19	20