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	109	109
Insufficient Information	63	63
Device Dislodged or Dislocated	61	61
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
Migration	10	10
Mechanical Jam	10	10
Naturally Worn	8	8
Difficult to Remove	7	7
Degraded	7	7
No Apparent Adverse Event	7	7
Use of Device Problem	6	6
Material Integrity Problem	6	6
Biocompatibility	5	5
Loosening of Implant Not Related to Bone-Ingrowth	5	5
Patient Device Interaction Problem	5	5
Loose or Intermittent Connection	5	5
Compatibility Problem	4	4
Device Appears to Trigger Rejection	4	4
Physical Resistance/Sticking	4	4
Material Fragmentation	3	3
Material Disintegration	3	3
Packaging Problem	3	3
Failure to Osseointegrate	3	3
Noise, Audible	3	3
Tear, Rip or Hole in Device Packaging	3	3
Delivered as Unsterile Product	3	3
Patient-Device Incompatibility	3	3
Inadequacy of Device Shape and/or Size	2	2
Entrapment of Device	2	2
Scratched Material	2	2
Unstable	2	2
Device Fell	2	2
Migration or Expulsion of Device	2	2
Malposition of Device	2	2
Unexpected Therapeutic Results	1	1
Expulsion	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Device-Device Incompatibility	1	1
Connection Problem	1	1
Component or Accessory Incompatibility	1	1
Defective Device	1	1
Separation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	97	97
Pain	79	79
No Clinical Signs, Symptoms or Conditions	69	69
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
Foreign Body Reaction	13	13
Loss of Range of Motion	13	13
Osteolysis	13	13
Joint Laxity	12	12
Limb Fracture	11	11
Fall	11	11
No Known Impact Or Consequence To Patient	9	9
Hypersensitivity/Allergic reaction	9	9
Hip Fracture	9	9
Unequal Limb Length	7	7
Joint Disorder	7	7
Injury	7	7
Patient Problem/Medical Problem	6	6
Discomfort	6	6
Bacterial Infection	5	5
Ambulation Difficulties	5	5
Swelling/ Edema	4	4
Unspecified Tissue Injury	4	4
Inflammation	4	4
Necrosis	4	4
Wound Dehiscence	4	4
Foreign Body In Patient	3	3
Synovitis	3	3
Swelling	3	3
Fatigue	3	3
Implant Pain	2	2
Test Result	2	2
Subluxation	2	2
Device Embedded In Tissue or Plaque	2	2
Fibrosis	2	2
Hemorrhage/Bleeding	2	2
Hematoma	2	2
Thrombosis/Thrombus	2	2
Fever	2	2
Edema	2	2
Dyspnea	2	2
Ossification	2	2
Shaking/Tremors	2	2