TPLC - Total Product Life Cycle

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Device	prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Regulation Description	Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Product Code	KWY
Regulation Number	888.3390
Device Class	2

Premarket Reviews
Manufacturer	Decision
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
G21, S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
HERAEUS MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAXX ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
WALDEMAR LINK GMBH & CO KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1074	1076
Device Dislodged or Dislocated	488	495
Naturally Worn	134	134
Fracture	115	122
Difficult to Insert	85	88
Insufficient Information	62	62
Migration	56	56
Loss of Osseointegration	50	50
Appropriate Term/Code Not Available	39	45
Material Erosion	34	35
Noise, Audible	31	32
Detachment of Device or Device Component	31	31
Loosening of Implant Not Related to Bone-Ingrowth	31	32
Loss of or Failure to Bond	25	26
Device Contaminated During Manufacture or Shipping	22	22
Corroded	21	29
Degraded	20	20
Osseointegration Problem	19	19
Break	19	20
Unintended Movement	16	16
Malposition of Device	15	16
Positioning Failure	15	16
Nonstandard Device	14	14
Use of Device Problem	14	14
Patient Device Interaction Problem	14	17
Unstable	11	11
Device-Device Incompatibility	10	10
Mechanical Problem	8	8
No Apparent Adverse Event	7	7
Separation Failure	7	7
Biocompatibility	6	6
Off-Label Use	6	6
Tear, Rip or Hole in Device Packaging	6	6
Fitting Problem	5	5
Mechanical Jam	5	6
Crack	5	6
Packaging Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Material Integrity Problem	5	5
Failure to Osseointegrate	4	4
Expiration Date Error	4	4
Loose or Intermittent Connection	4	4
Positioning Problem	4	4
Device Damaged Prior to Use	3	3
Difficult to Remove	3	4
Activation, Positioning or Separation Problem	3	3
Patient-Device Incompatibility	2	2
Defective Device	2	2
Product Quality Problem	2	2
Scratched Material	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	851	851
Pain	507	514
Joint Dislocation	435	442
Unspecified Infection	359	361
Test Result	169	169
No Clinical Signs, Symptoms or Conditions	163	170
Foreign Body Reaction	156	156
Insufficient Information	139	141
Bone Fracture(s)	123	124
Failure of Implant	114	120
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	74	75
Inadequate Osseointegration	74	74
Joint Laxity	73	73
Osteolysis	70	71
Fall	66	69
Hypersensitivity/Allergic reaction	63	63
Discomfort	55	56
Injury	44	50
Edema	42	42
No Consequences Or Impact To Patient	41	41
Limited Mobility Of The Implanted Joint	40	40
Metal Related Pathology	40	43
Hematoma	39	39
No Information	38	38
Ambulation Difficulties	35	36
Inflammation	30	31
Necrosis	30	36
No Known Impact Or Consequence To Patient	29	29
Loss of Range of Motion	24	24
Tissue Damage	23	23
Not Applicable	23	23
Adhesion(s)	21	21
Thrombosis	19	19
Cyst(s)	19	21
No Patient Involvement	18	18
Ossification	18	18
Fatigue	17	24
Hip Fracture	16	16
Nerve Damage	14	15
Hemorrhage/Bleeding	14	14
Weakness	14	14
Arthralgia	13	13
Impaired Healing	12	12
Pulmonary Embolism	12	13
Osteopenia/ Osteoporosis	12	12
Wound Dehiscence	11	11
Muscle/Tendon Damage	11	12
Local Reaction	11	11
Swelling/ Edema	11	12
Implant Pain	10	10