TPLC - Total Product Life Cycle

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Device	prosthesis, hip, femoral, resurfacing
Regulation Description	Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
Product Code	KXA
Regulation Number	888.3400
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	169	169
Migration	79	79
Device Dislodged or Dislocated	41	41
Loss of Osseointegration	21	21
Naturally Worn	18	18
Insufficient Information	18	18
Corroded	13	13
Material Disintegration	9	9
Fracture	9	9
Noise, Audible	8	8
Biocompatibility	8	8
Loss of or Failure to Bond	8	8
Osseointegration Problem	7	7
Appropriate Term/Code Not Available	6	6
Material Erosion	6	6
Degraded	6	6
Malposition of Device	5	5
Unintended Movement	5	5
Loosening of Implant Not Related to Bone-Ingrowth	5	5
Nonstandard Device	4	4
Inadequacy of Device Shape and/or Size	4	4
Use of Device Problem	4	4
Off-Label Use	4	4
Break	4	4
Patient-Device Incompatibility	3	3
Particulates	2	2
Material Integrity Problem	2	2
Illegible Information	2	2
Physical Resistance/Sticking	2	2
Output Problem	2	2
Migration or Expulsion of Device	2	2
Loose or Intermittent Connection	2	2
Entrapment of Device	2	2
Difficult to Insert	1	1
Patient Device Interaction Problem	1	1
Scratched Material	1	1
Packaging Problem	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
No Apparent Adverse Event	1	1
Expiration Date Error	1	1
Mechanical Problem	1	1
Mechanical Jam	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device-Device Incompatibility	1	1
Activation, Positioning or Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	238	238
Pain	159	159
No Consequences Or Impact To Patient	86	86
Test Result	70	70
Foreign Body Reaction	69	69
No Patient Involvement	68	68
Unspecified Infection	42	42
Joint Dislocation	36	36
Osteolysis	26	26
Metal Related Pathology	26	26
Edema	23	23
Bone Fracture(s)	20	20
Hypersensitivity/Allergic reaction	15	15
Limited Mobility Of The Implanted Joint	15	15
Inadequate Osseointegration	14	14
Tissue Damage	13	13
Thrombosis	11	11
Discomfort	10	10
Injury	10	10
Reaction	10	10
Adhesion(s)	10	10
Not Applicable	8	8
Fatigue	8	8
Insufficient Information	7	7
Pulmonary Embolism	6	6
Weakness	6	6
Necrosis	6	6
No Information	6	6
Failure of Implant	6	6
Memory Loss/Impairment	5	5
Inflammation	5	5
Toxicity	5	5
Hematoma	4	4
Cyst(s)	4	4
Neuropathy	4	4
No Known Impact Or Consequence To Patient	4	4
Hearing Impairment	4	4
Nerve Damage	4	4
Tinnitus	4	4
Anxiety	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Swelling/ Edema	3	3
Fall	3	3
Ossification	3	3
Loss of Range of Motion	3	3
Joint Disorder	3	3
Pneumonia	2	2
Hair Loss	2	2
Pocket Erosion	2	2
Myocardial Infarction	2	2