TPLC - Total Product Life Cycle

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Device	prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Regulation Description	Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Product Code	KWY
Regulation Number	888.3390
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	460	462
Device Dislodged or Dislocated	267	274
Fracture	75	82
Difficult to Insert	66	69
Naturally Worn	31	31
Detachment of Device or Device Component	27	27
Insufficient Information	24	24
Loosening of Implant Not Related to Bone-Ingrowth	22	23
Appropriate Term/Code Not Available	19	19
Material Erosion	19	20
Break	15	16
Patient Device Interaction Problem	14	17
Loss of Osseointegration	12	12
Positioning Failure	10	11
Unstable	8	8
Device Contaminated During Manufacture or Shipping	8	8
Migration	7	7
Loss of or Failure to Bond	6	7
No Apparent Adverse Event	6	6
Biocompatibility	5	5
Tear, Rip or Hole in Device Packaging	5	5
Material Integrity Problem	5	5
Positioning Problem	5	5
Mechanical Problem	4	4
Crack	4	4
Packaging Problem	4	4
Failure to Osseointegrate	4	4
Noise, Audible	3	3
Osseointegration Problem	3	3
Mechanical Jam	3	4
Corroded	3	4
Use of Device Problem	3	3
Degraded	3	3
Expiration Date Error	3	3
Device Damaged Prior to Use	3	3
Malposition of Device	3	4
Off-Label Use	3	3
Device-Device Incompatibility	3	3
Fitting Problem	3	3
Difficult to Remove	2	3
Manufacturing, Packaging or Shipping Problem	2	2
Product Quality Problem	2	2
Patient-Device Incompatibility	2	2
Separation Failure	2	2
Device Markings/Labelling Problem	2	2
Loose or Intermittent Connection	2	2
Separation Problem	2	2
Activation, Positioning or Separation Problem	2	2
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	246	253
Unspecified Infection	160	162
No Clinical Signs, Symptoms or Conditions	153	160
Pain	140	146
Insufficient Information	126	128
Failure of Implant	99	105
Joint Laxity	68	68
Bone Fracture(s)	53	54
Fall	45	48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	41
Metal Related Pathology	38	41
Inadequate Osseointegration	24	24
Osteolysis	17	18
Ambulation Difficulties	13	14
Loss of Range of Motion	13	13
Hematoma	12	12
Muscle/Tendon Damage	11	12
Arthralgia	11	11
Implant Pain	10	10
Hip Fracture	10	10
Foreign Body Reaction	9	9
Discomfort	9	9
Fluid Discharge	8	8
Limb Fracture	8	8
Hypersensitivity/Allergic reaction	8	8
Local Reaction	8	8
Osteopenia/ Osteoporosis	8	8
Unspecified Tissue Injury	7	8
Wound Dehiscence	7	7
No Information	6	6
Necrosis	6	6
Inflammation	5	5
Swelling/ Edema	5	6
Physical Asymmetry	5	5
Ossification	5	5
Sleep Dysfunction	5	5
Cyst(s)	4	5
Adhesion(s)	4	4
Scar Tissue	4	4
Dyspnea	4	4
Post Operative Wound Infection	4	4
Bacterial Infection	4	4
Non-union Bone Fracture	3	3
Erythema	3	3
Unequal Limb Length	3	3
Nerve Damage	3	4
Numbness	3	4
Hemorrhage/Bleeding	3	3
Thrombosis/Thrombus	2	3
Swollen Lymph Nodes/Glands	2	3