TPLC - Total Product Life Cycle

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Device	prosthesis, hip, femoral, resurfacing
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	605	605
Device Dislodged or Dislocated	185	185
Migration	152	152
Naturally Worn	131	131
Loss of Osseointegration	113	113
Corroded	68	68
Fracture	47	47
Loss of or Failure to Bond	44	44
Osseointegration Problem	43	43
Degraded	43	43
Insufficient Information	32	32
Biocompatibility	25	25
Noise, Audible	25	25
Use of Device Problem	24	24
Nonstandard Device	23	23
Unintended Movement	17	17
Malposition of Device	15	15
Appropriate Term/Code Not Available	11	11
Inadequacy of Device Shape and/or Size	11	11
Break	9	9
Material Erosion	8	8
Loose or Intermittent Connection	7	7
Loosening of Implant Not Related to Bone-Ingrowth	6	6
Material Disintegration	6	6
Failure to Osseointegrate	5	5
Off-Label Use	4	4
Migration or Expulsion of Device	3	3
Patient-Device Incompatibility	3	3
Particulates	2	2
Illegible Information	2	2
Physical Resistance/Sticking	2	2
Output Problem	2	2
Entrapment of Device	2	2
Device-Device Incompatibility	2	2
Expiration Date Error	2	2
Material Integrity Problem	2	2
Difficult or Delayed Separation	1	1
Packaging Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Incorrect Measurement	1	1
Device Contamination with Chemical or Other Material	1	1
Material Separation	1	1
No Apparent Adverse Event	1	1
Difficult to Insert	1	1
Patient Device Interaction Problem	1	1
Scratched Material	1	1
Mechanical Problem	1	1
Incomplete or Missing Packaging	1	1
Mechanical Jam	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	1023	1023
Pain	589	589
Foreign Body Reaction	257	257
Unspecified Infection	242	242
Test Result	225	225
Joint Dislocation	181	181
Bone Fracture(s)	140	140
No Consequences Or Impact To Patient	129	129
Osteolysis	112	112
Hypersensitivity/Allergic reaction	106	106
Inadequate Osseointegration	102	102
No Patient Involvement	68	68
Limited Mobility Of The Implanted Joint	61	61
Injury	56	56
Tissue Damage	52	52
Thrombosis	45	45
Not Applicable	38	38
Edema	37	37
Pulmonary Embolism	31	31
Discomfort	25	25
Metal Related Pathology	24	24
Loss of Range of Motion	24	24
Reaction	20	20
Necrosis	20	20
Hematoma	20	20
Adhesion(s)	17	17
Inflammation	17	17
Sepsis	15	15
Ossification	15	15
Hemorrhage/Bleeding	14	14
Myocardial Infarction	11	11
Fatigue	10	10
Weakness	10	10
No Information	10	10
Joint Disorder	9	9
Cyst(s)	9	9
Death	8	8
Stroke/CVA	8	8
Toxicity	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Nerve Damage	7	7
Swelling	7	7
Memory Loss/Impairment	7	7
Ambulation Difficulties	7	7
Anxiety	6	6
Post Operative Wound Infection	6	6
No Known Impact Or Consequence To Patient	6	6
Failure of Implant	6	6
Pneumonia	6	6
Neuropathy	6	6