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	135	141
Break	117	117
Insufficient Information	70	70
Device Dislodged or Dislocated	63	64
Fracture	56	56
Loss of Osseointegration	23	23
Osseointegration Problem	23	25
Corroded	22	22
Mechanical Jam	18	18
Detachment of Device or Device Component	14	14
Mechanical Problem	12	12
Appropriate Term/Code Not Available	12	12
Naturally Worn	10	10
Migration	10	10
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
Noise, Audible	5	5
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
Patient-Device Incompatibility	4	4
Delivered as Unsterile Product	4	4
Tear, Rip or Hole in Device Packaging	3	3
Packaging Problem	3	3
Failure to Osseointegrate	3	3
Material Fragmentation	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	110	111
Pain	82	87
No Clinical Signs, Symptoms or Conditions	76	76
No Information	62	62
Failure of Implant	61	61
Bone Fracture(s)	59	60
Unspecified Infection	43	43
Inadequate Osseointegration	28	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	28
Metal Related Pathology	23	24
No Code Available	20	21
Joint Dislocation	17	20
Osteolysis	13	13
Loss of Range of Motion	13	14
Foreign Body Reaction	13	15
Joint Laxity	12	13
Fall	12	13
Limb Fracture	11	12
Hypersensitivity/Allergic reaction	9	11
Hip Fracture	9	9
No Known Impact Or Consequence To Patient	9	9
Joint Disorder	7	7
Discomfort	7	9
Unequal Limb Length	7	7
Injury	7	7
Patient Problem/Medical Problem	6	6
Ambulation Difficulties	5	8
Bacterial Infection	5	5
Unspecified Tissue Injury	4	6
Wound Dehiscence	4	4
Swelling/ Edema	4	5
Necrosis	4	5
Inflammation	4	7
Swelling	3	6
Foreign Body In Patient	3	3
Fatigue	3	7
Synovitis	3	3
Distress	2	4
Device Embedded In Tissue or Plaque	2	2
Hemorrhage/Bleeding	2	2
Fibrosis	2	2
Shaking/Tremors	2	5
Toxicity	2	5
Subluxation	2	2
Reaction	2	2
Dyspnea	2	3
Test Result	2	2
Hematoma	2	2
Fever	2	2
Thrombosis/Thrombus	2	2