TPLC - Total Product Life Cycle

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Device	prosthesis, hip, semi-constrained, metal/polymer, uncemented
Regulation Description	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product Code	LWJ
Regulation Number	888.3360
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	128	128
Break	107	107
Device Dislodged or Dislocated	60	60
Insufficient Information	59	59
Fracture	53	53
Loss of Osseointegration	23	23
Osseointegration Problem	23	23
Corroded	20	20
Detachment of Device or Device Component	14	14
Mechanical Problem	12	12
Appropriate Term/Code Not Available	12	12
Mechanical Jam	10	10
Migration	10	10
Naturally Worn	8	8
No Apparent Adverse Event	7	7
Difficult to Remove	7	7
Degraded	7	7
Material Integrity Problem	6	6
Use of Device Problem	6	6
Biocompatibility	5	5
Loose or Intermittent Connection	5	5
Patient Device Interaction Problem	5	5
Loosening of Implant Not Related to Bone-Ingrowth	5	5
Compatibility Problem	4	4
Device Appears to Trigger Rejection	4	4
Physical Resistance/Sticking	4	4
Noise, Audible	3	3
Tear, Rip or Hole in Device Packaging	3	3
Packaging Problem	3	3
Delivered as Unsterile Product	3	3
Failure to Osseointegrate	3	3
Material Fragmentation	3	3
Patient-Device Incompatibility	3	3
Material Disintegration	3	3
Scratched Material	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Fell	2	2
Malposition of Device	2	2
Migration or Expulsion of Device	2	2
Entrapment of Device	2	2
Unstable	2	2
Difficult to Insert	1	1
Material Discolored	1	1
Device Difficult to Setup or Prepare	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Positioning Problem	1	1
Measurement System Incompatibility	1	1
Material Deformation	1	1
Defective Device	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	92	92
Pain	79	79
No Clinical Signs, Symptoms or Conditions	67	67
No Information	62	62
Failure of Implant	58	58
Bone Fracture(s)	56	56
Unspecified Infection	39	39
Inadequate Osseointegration	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Metal Related Pathology	22	22
No Code Available	20	20
Joint Dislocation	17	17
Osteolysis	13	13
Loss of Range of Motion	13	13
Foreign Body Reaction	13	13
Joint Laxity	12	12
Limb Fracture	11	11
Fall	11	11
Hypersensitivity/Allergic reaction	9	9
Hip Fracture	9	9
No Known Impact Or Consequence To Patient	9	9
Joint Disorder	7	7
Unequal Limb Length	7	7
Injury	7	7
Patient Problem/Medical Problem	6	6
Discomfort	6	6
Ambulation Difficulties	5	5
Bacterial Infection	5	5
Swelling/ Edema	4	4
Unspecified Tissue Injury	4	4
Inflammation	4	4
Wound Dehiscence	4	4
Necrosis	4	4
Synovitis	3	3
Foreign Body In Patient	3	3
Swelling	3	3
Fatigue	3	3
Implant Pain	2	2
Device Embedded In Tissue or Plaque	2	2
Edema	2	2
Distress	2	2
Fibrosis	2	2
Ossification	2	2
Hematoma	2	2
Hemorrhage/Bleeding	2	2
Fever	2	2
Thrombosis/Thrombus	2	2
Test Result	2	2
Shaking/Tremors	2	2
Toxicity	2	2