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. DBA DJO SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, LP
	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
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIGNAL MEDICAL CORPORATION
	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	3143	3502
Fracture	1022	1282
Unstable	827	836
Insufficient Information	583	586
Loss of Osseointegration	340	340
Break	319	320
Loosening of Implant Not Related to Bone-Ingrowth	258	264
Detachment of Device or Device Component	231	235
Difficult to Insert	203	204
Osseointegration Problem	180	449
Naturally Worn	154	156
Migration	140	143
Device Dislodged or Dislocated	118	120
Degraded	117	117
Mechanical Problem	101	103
Malposition of Device	94	328
Positioning Failure	84	84
Noise, Audible	78	79
Loss of or Failure to Bond	70	73
Use of Device Problem	61	62
Material Erosion	56	290
Patient Device Interaction Problem	53	56
Unintended Movement	52	52
Material Deformation	50	50
Loose or Intermittent Connection	47	48
Connection Problem	46	46
Appropriate Term/Code Not Available	38	41
Dull, Blunt	29	29
Crack	29	29
Device Contaminated During Manufacture or Shipping	27	27
Inadequacy of Device Shape and/or Size	26	26
Component Missing	22	22
Mechanical Jam	22	22
Packaging Problem	21	21
Failure to Osseointegrate	21	21
Tear, Rip or Hole in Device Packaging	20	20
Incomplete or Inadequate Connection	17	17
Device Damaged Prior to Use	17	17
Corroded	16	16
Device-Device Incompatibility	16	16
Off-Label Use	15	16
Material Fragmentation	15	15
Improper or Incorrect Procedure or Method	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
Material Separation	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	1937	2232
No Clinical Signs, Symptoms or Conditions	1715	1736
Unspecified Infection	899	1172
Joint Laxity	870	1138
Insufficient Information	743	1017
Loss of Range of Motion	697	804
Ambulation Difficulties	506	513
Inadequate Osseointegration	456	461
Swelling/ Edema	398	402
Failure of Implant	360	378
Injury	350	350
Scar Tissue	224	224
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	82	317
Inflammation	80	81
No Consequences Or Impact To Patient	76	76
Muscular Rigidity	74	75
Discomfort	63	63
Muscle/Tendon Damage	62	62
Thrombosis/Thrombus	58	58
Fibrosis	52	52
No Information	52	55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	51	51
Hypersensitivity/Allergic reaction	48	50
Osteolysis	48	283
Damage to Ligament(s)	45	46
Unspecified Tissue Injury	43	43
Synovitis	42	278
Swelling	38	40
Limited Mobility Of The Implanted Joint	38	38
Bacterial Infection	35	35
Numbness	35	35
Metal Related Pathology	34	268
Hematoma	30	31
Wound Dehiscence	28	29
Implant Pain	27	27
Fluid Discharge	24	26
Pulmonary Embolism	24	24
Foreign Body Reaction	22	23
Impaired Healing	21	21
Subluxation	21	22
Nerve Damage	21	22
Aspiration/Inhalation	20	20
Cellulitis	20	22
Cyst(s)	19	20
Necrosis	19	20