TPLC - Total Product Life Cycle

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Device	prosthesis, hip, semi-constrained, metal/polymer, uncemented
Product Code	LWJ
Regulation Number	888.3360
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	140	140
Adverse Event Without Identified Device or Use Problem	137	137
Insufficient Information	107	107
Device Dislodged or Dislocated	91	91
Fracture	57	57
Loose or Intermittent Connection	47	47
Loss of Osseointegration	28	28
Osseointegration Problem	26	26
Corroded	24	24
Detachment of Device or Device Component	13	13
Appropriate Term/Code Not Available	12	12
Migration	11	11
Mechanical Problem	10	10
Material Integrity Problem	10	10
Compatibility Problem	8	8
Naturally Worn	8	8
Difficult to Remove	8	8
Degraded	8	8
No Apparent Adverse Event	7	7
Material Fragmentation	7	7
Patient Device Interaction Problem	7	7
Use of Device Problem	6	6
Loosening of Implant Not Related to Bone-Ingrowth	6	6
Biocompatibility	5	5
Mechanical Jam	5	5
Physical Resistance/Sticking	4	4
Noise, Audible	3	3
Device Appears to Trigger Rejection	3	3
Tear, Rip or Hole in Device Packaging	3	3
Packaging Problem	3	3
Device Difficult to Setup or Prepare	3	3
Material Disintegration	3	3
Malposition of Device	3	3
Migration or Expulsion of Device	3	3
Unstable	3	3
Scratched Material	2	2
Failure to Osseointegrate	2	2
Delivered as Unsterile Product	2	2
Device Fell	2	2
Patient-Device Incompatibility	2	2
Entrapment of Device	2	2
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Difficult to Insert	1	1
Positioning Failure	1	1
Material Discolored	1	1
Positioning Problem	1	1
Measurement System Incompatibility	1	1
Problem with Sterilization	1	1
Defective Device	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Information	185	185
Pain	90	90
Insufficient Information	82	82
Unspecified Infection	65	65
Bone Fracture(s)	59	59
Failure of Implant	56	56
No Clinical Signs, Symptoms or Conditions	55	55
No Code Available	39	39
Inadequate Osseointegration	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Joint Dislocation	24	24
Metal Related Pathology	21	21
Injury	17	17
Patient Problem/Medical Problem	15	15
Foreign Body Reaction	15	15
Loss of Range of Motion	14	14
Osteolysis	13	13
Fall	13	13
Joint Laxity	12	12
No Known Impact Or Consequence To Patient	11	11
Limb Fracture	11	11
Hypersensitivity/Allergic reaction	9	9
Hip Fracture	9	9
Joint Disorder	9	9
Foreign Body In Patient	7	7
Discomfort	7	7
Unequal Limb Length	6	6
Reaction	6	6
Inflammation	6	6
Ambulation Difficulties	5	5
Bacterial Infection	5	5
Necrosis	5	5
Unspecified Tissue Injury	4	4
Test Result	4	4
Swelling/ Edema	4	4
No Consequences Or Impact To Patient	4	4
Death	4	4
Wound Dehiscence	4	4
Synovitis	3	3
Tissue Damage	3	3
Fatigue	3	3
Swelling	3	3
Ossification	3	3
Shaking/Tremors	2	2
Toxicity	2	2
Dyspnea	2	2
Hemorrhage/Bleeding	2	2
Fibrosis	2	2
Thrombosis/Thrombus	2	2
Distress	2	2