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
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
1. K221794 Vario-Cup System

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1028	1028
Device Dislodged or Dislocated	453	453
Naturally Worn	134	134
Fracture	114	114
Difficult to Insert	74	74
Insufficient Information	62	62
Migration	56	56
Loss of Osseointegration	49	49
Appropriate Term/Code Not Available	39	39
Material Erosion	31	31
Noise, Audible	30	30
Loosening of Implant Not Related to Bone-Ingrowth	30	30
Detachment of Device or Device Component	29	29
Loss of or Failure to Bond	25	25
Device Contaminated During Manufacture or Shipping	21	21
Corroded	20	20
Degraded	20	20
Osseointegration Problem	19	19
Break	18	18
Unintended Movement	16	16
Malposition of Device	15	15
Patient Device Interaction Problem	15	15
Nonstandard Device	14	14
Use of Device Problem	14	14
Positioning Failure	13	13
Unstable	11	11
Device-Device Incompatibility	10	10
Mechanical Problem	8	8
Separation Failure	7	7
Biocompatibility	6	6
No Apparent Adverse Event	6	6
Off-Label Use	6	6
Material Integrity Problem	5	5
Fitting Problem	5	5
Mechanical Jam	5	5
Positioning Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Failure to Osseointegrate	4	4
Packaging Problem	4	4
Loose or Intermittent Connection	4	4
Tear, Rip or Hole in Device Packaging	4	4
Crack	4	4
Difficult to Remove	3	3
Expiration Date Error	3	3
Activation, Positioning or Separation Problem	3	3
Device Damaged Prior to Use	3	3
Scratched Material	2	2
Defective Device	2	2
Patient-Device Incompatibility	2	2
Deformation Due to Compressive Stress	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	854	854
Pain	496	496
Joint Dislocation	405	405
Unspecified Infection	341	341
Test Result	171	171
Foreign Body Reaction	156	156
No Clinical Signs, Symptoms or Conditions	144	144
Insufficient Information	124	124
Bone Fracture(s)	122	122
Failure of Implant	113	113
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	73	73
Inadequate Osseointegration	73	73
Osteolysis	70	70
Joint Laxity	65	65
Hypersensitivity/Allergic reaction	63	63
Fall	62	62
Discomfort	53	53
Injury	44	44
Edema	42	42
No Consequences Or Impact To Patient	41	41
Limited Mobility Of The Implanted Joint	40	40
Metal Related Pathology	40	40
Hematoma	39	39
No Information	38	38
Ambulation Difficulties	37	37
Necrosis	31	31
No Known Impact Or Consequence To Patient	29	29
Inflammation	28	28
Loss of Range of Motion	23	23
Not Applicable	23	23
Tissue Damage	23	23
Adhesion(s)	21	21
Thrombosis	19	19
Ossification	18	18
No Patient Involvement	18	18
Cyst(s)	18	18
Fatigue	17	17
Hip Fracture	16	16
Hemorrhage/Bleeding	14	14
Nerve Damage	14	14
Weakness	14	14
Pulmonary Embolism	12	12
Osteopenia/ Osteoporosis	12	12
Impaired Healing	12	12
Local Reaction	11	11
Unspecified Tissue Injury	11	11
Muscle/Tendon Damage	10	10
Scar Tissue	10	10
Swelling/ Edema	10	10
Physical Asymmetry	10	10