TPLC - Total Product Life Cycle

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Device	prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Product Code	KWY
Regulation Number	888.3390
Device Class	2

Premarket Reviews
Manufacturer	Decision
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
G21, S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
HERAEUS MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
IMPLANTCAST, GMBH
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
THEKEN COMPANIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1603	1603
Device Dislodged or Dislocated	819	819
Naturally Worn	399	399
Fracture	181	181
Insufficient Information	105	105
Difficult to Insert	88	88
Loss of Osseointegration	80	80
Migration	77	77
Noise, Audible	62	62
Appropriate Term/Code Not Available	60	60
Corroded	59	59
Loosening of Implant Not Related to Bone-Ingrowth	44	44
Material Erosion	43	43
Loss of or Failure to Bond	42	42
Biocompatibility	37	37
Detachment of Device or Device Component	34	34
Nonstandard Device	32	32
Degraded	31	31
Osseointegration Problem	28	28
Break	25	25
Use of Device Problem	25	25
Unintended Movement	23	23
Malposition of Device	22	22
Device Contaminated During Manufacture or Shipping	21	21
Delivered as Unsterile Product	20	20
Patient Device Interaction Problem	19	19
Unstable	14	14
Packaging Problem	12	12
Positioning Failure	12	12
Device-Device Incompatibility	10	10
No Apparent Adverse Event	9	9
Separation Failure	8	8
Off-Label Use	8	8
Difficult to Remove	7	7
Failure to Osseointegrate	7	7
Fitting Problem	7	7
Mechanical Problem	7	7
Loose or Intermittent Connection	6	6
Inadequacy of Device Shape and/or Size	5	5
Patient-Device Incompatibility	5	5
Mechanical Jam	5	5
Material Integrity Problem	5	5
Positioning Problem	5	5
Scratched Material	4	4
Device Damaged Prior to Use	4	4
Crack	4	4
Expiration Date Error	3	3
Tear, Rip or Hole in Device Packaging	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Contamination /Decontamination Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	1995	1998
Pain	1100	1101
Joint Dislocation	739	740
Unspecified Infection	622	623
Test Result	421	421
Foreign Body Reaction	352	352
Osteolysis	222	222
Injury	169	169
Bone Fracture(s)	162	162
Tissue Damage	156	156
Hypersensitivity/Allergic reaction	154	154
No Clinical Signs, Symptoms or Conditions	132	132
Limited Mobility Of The Implanted Joint	124	124
Insufficient Information	113	113
Failure of Implant	113	113
Inadequate Osseointegration	112	112
Discomfort	109	109
Loss of Range of Motion	89	89
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	77	77
No Consequences Or Impact To Patient	76	76
Inflammation	74	74
No Information	68	68
Edema	67	67
Hematoma	63	63
Fall	62	62
Necrosis	62	62
Not Applicable	60	60
Thrombosis	60	60
Joint Laxity	57	57
Ambulation Difficulties	49	49
No Known Impact Or Consequence To Patient	47	47
Pulmonary Embolism	45	45
No Patient Involvement	43	43
Metal Related Pathology	42	42
Adhesion(s)	37	37
Weakness	32	32
Ossification	30	30
Fatigue	27	27
Scar Tissue	27	27
Cyst(s)	26	26
Hemorrhage/Bleeding	25	25
Reaction	21	21
Swelling	20	20
Nerve Damage	19	19
Hip Fracture	17	17
Unspecified Tissue Injury	16	16
Anxiety	15	15
Local Reaction	15	15
Impaired Healing	15	15
Joint Disorder	15	15