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	143	143
Adverse Event Without Identified Device or Use Problem	140	140
Insufficient Information	114	114
Device Dislodged or Dislocated	91	91
Fracture	59	59
Loose or Intermittent Connection	47	47
Loss of Osseointegration	28	28
Osseointegration Problem	26	26
Corroded	25	25
Detachment of Device or Device Component	13	13
Appropriate Term/Code Not Available	12	12
Mechanical Problem	11	11
Migration	11	11
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
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
Failure to Osseointegrate	3	3
Device Difficult to Setup or Prepare	3	3
Patient-Device Incompatibility	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
Delivered as Unsterile Product	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Fell	2	2
Entrapment of Device	2	2
Difficult to Insert	1	1
Positioning Failure	1	1
Material Discolored	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Positioning Problem	1	1
Problem with Sterilization	1	1
Measurement System Incompatibility	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Information	185	185
Pain	93	93
Insufficient Information	85	85
Unspecified Infection	67	67
No Clinical Signs, Symptoms or Conditions	61	61
Bone Fracture(s)	60	60
Failure of Implant	58	58
No Code Available	39	39
Inadequate Osseointegration	34	34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Joint Dislocation	24	24
Metal Related Pathology	22	22
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	7	7
Reaction	6	6
Inflammation	6	6
Necrosis	5	5
Bacterial Infection	5	5
Ambulation Difficulties	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
Ossification	3	3
Swelling	3	3
Shaking/Tremors	2	2
Toxicity	2	2
Subluxation	2	2
Dyspnea	2	2
Hemorrhage/Bleeding	2	2
Fibrosis	2	2
Distress	2	2