TPLC - Total Product Life Cycle

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Device	prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Product Code	KWZ
Regulation Number	888.3310
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	638	638
Adverse Event Without Identified Device or Use Problem	333	333
Naturally Worn	135	135
Fracture	123	123
Device Contaminated During Manufacture or Shipping	68	68
Insufficient Information	55	55
Appropriate Term/Code Not Available	48	48
Detachment of Device or Device Component	48	48
Difficult to Insert	29	29
Unstable	26	26
Break	24	24
Noise, Audible	18	18
Packaging Problem	15	15
Loosening of Implant Not Related to Bone-Ingrowth	13	13
Material Deformation	13	13
Device-Device Incompatibility	12	12
Off-Label Use	12	12
Positioning Failure	12	12
Loose or Intermittent Connection	11	11
Nonstandard Device	10	10
Scratched Material	9	9
Unintended Movement	8	8
Malposition of Device	7	7
Separation Failure	7	7
Migration	7	7
Material Erosion	6	6
Loss of or Failure to Bond	6	6
Tear, Rip or Hole in Device Packaging	6	6
Fitting Problem	5	5
Mechanical Problem	5	5
Biocompatibility	5	5
Loss of Osseointegration	5	5
Difficult to Remove	5	5
Use of Device Problem	5	5
Inadequacy of Device Shape and/or Size	5	5
Contamination /Decontamination Problem	4	4
Patient Device Interaction Problem	4	4
Deformation Due to Compressive Stress	3	3
Improper or Incorrect Procedure or Method	3	3
Connection Problem	3	3
Material Twisted/Bent	3	3
Device Difficult to Setup or Prepare	3	3
Shipping Damage or Problem	3	3
Material Separation	2	2
Failure to Osseointegrate	2	2
Component Missing	2	2
Illegible Information	2	2
Degraded	2	2
Difficult to Open or Close	2	2
Corroded	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	558	558
No Code Available	430	430
Pain	210	210
Unspecified Infection	152	152
Injury	97	97
Insufficient Information	91	91
No Clinical Signs, Symptoms or Conditions	89	89
Osteolysis	58	58
No Patient Involvement	56	56
Foreign Body Reaction	55	55
Joint Laxity	54	54
Failure of Implant	44	44
No Information	43	43
Fall	40	40
No Known Impact Or Consequence To Patient	38	38
Ambulation Difficulties	33	33
No Consequences Or Impact To Patient	33	33
Tissue Damage	32	32
Test Result	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	28	28
Limited Mobility Of The Implanted Joint	26	26
Loss of Range of Motion	25	25
Hypersensitivity/Allergic reaction	23	23
Bone Fracture(s)	20	20
Discomfort	17	17
Not Applicable	17	17
Hematoma	14	14
Scar Tissue	12	12
Ossification	11	11
Osteopenia/ Osteoporosis	11	11
Inflammation	11	11
Adhesion(s)	10	10
Edema	10	10
Thrombosis	9	9
Inadequate Osseointegration	9	9
Unspecified Tissue Injury	8	8
Swelling	7	7
Weakness	7	7
Necrosis	7	7
Metal Related Pathology	7	7
Joint Disorder	7	7
Pulmonary Embolism	7	7
Swelling/ Edema	6	6
Cyst(s)	6	6
Impaired Healing	6	6
Reaction	6	6
Fatigue	6	6
Hemorrhage/Bleeding	5	5
Erosion	4	4
Unspecified Musculoskeletal problem	4	4