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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1024	1024
Device Dislodged or Dislocated	449	449
Naturally Worn	134	134
Fracture	113	113
Difficult to Insert	73	73
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	9	9
Mechanical Problem	8	8
Separation Failure	7	7
Biocompatibility	6	6
No Apparent Adverse Event	6	6
Off-Label Use	6	6
Fitting Problem	5	5
Material Integrity Problem	5	5
Mechanical Jam	5	5
Positioning Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Failure to Osseointegrate	4	4
Loose or Intermittent Connection	4	4
Packaging Problem	4	4
Tear, Rip or Hole in Device Packaging	4	4
Crack	4	4
Difficult to Remove	3	3
Activation, Positioning or Separation Problem	3	3
Expiration Date Error	3	3
Device Damaged Prior to Use	3	3
Scratched Material	2	2
Patient-Device Incompatibility	2	2
Deformation Due to Compressive Stress	2	2
Separation Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	854	854
Pain	495	495
Joint Dislocation	401	401
Unspecified Infection	339	339
Test Result	171	171
Foreign Body Reaction	156	156
No Clinical Signs, Symptoms or Conditions	143	143
Insufficient Information	122	122
Bone Fracture(s)	121	121
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	64	64
Hypersensitivity/Allergic reaction	63	63
Fall	62	62
Discomfort	52	52
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
Tissue Damage	23	23
Not Applicable	23	23
Adhesion(s)	21	21
Thrombosis	19	19
No Patient Involvement	18	18
Ossification	18	18
Cyst(s)	18	18
Fatigue	17	17
Hip Fracture	16	16
Hemorrhage/Bleeding	14	14
Weakness	14	14
Nerve Damage	14	14
Pulmonary Embolism	12	12
Impaired Healing	12	12
Osteopenia/ Osteoporosis	12	12
Unspecified Tissue Injury	11	11
Local Reaction	11	11
Scar Tissue	10	10
Muscle/Tendon Damage	10	10
Swelling/ Edema	10	10
Arthralgia	10	10