TPLC - Total Product Life Cycle

show TPLC since

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	475	477
Device Dislodged or Dislocated	283	290
Fracture	77	84
Difficult to Insert	69	72
Naturally Worn	31	31
Detachment of Device or Device Component	29	29
Insufficient Device Problem Information	23	23
Loosening of Implant Not Related to Bone-Ingrowth	22	23
Material Erosion	22	23
Break	14	15
Patient Device Interaction Problem	12	14
Positioning Failure	12	13
Loss of Osseointegration	12	12
Unstable	10	10
Migration	8	8
Device Contaminated During Manufacture or Shipping	8	8
Loss of or Failure to Bond	7	8
No Apparent Adverse Event	6	6
Mechanical Problem	5	5
Positioning Problem	5	5
Material Integrity Problem	5	5
Biocompatibility	5	5
Tear, Rip or Hole in Device Packaging	5	5
Packaging Problem	4	4
Mechanical Jam	4	5
Failure to Osseointegrate	4	4
Osseointegration Problem	3	3
Device-Device Incompatibility	3	3
Expiration Date Error	3	3
Device Damaged Prior to Use	3	3
Fitting Problem	3	3
Device Slipped	3	3
Difficult to Remove	3	4
Off-Label Use	3	3
Degraded	3	3
Crack	3	3
Separation Failure	2	2
Malposition of Device	2	2
Activation, Positioning or Separation Problem	2	2
Device Markings/Labelling Problem	2	2
Use of Device Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Deformation	2	2
Product Quality Problem	2	2
Noise, Audible	2	2
Corroded	2	3
Separation Problem	2	2
Solder Joint Fracture	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	269	276
Unspecified Infection	169	171
No Clinical Signs, Symptoms or Conditions	162	169
Pain	142	148
Insufficient Information	135	137
Failure of Implant	100	106
Joint Laxity	73	73
Bone Fracture(s)	57	58
Fall	49	52
Metal Related Pathology	42	45
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	40	41
Medical device site infection	37	37
Inadequate Osseointegration	24	24
Osteolysis	19	20
Ambulation or Postural Difficulties	14	15
Loss of Range of Motion	13	13
Muscle/Tendon Damage	13	14
Hematoma	12	12
Arthralgia	11	11
High metal ion levels	11	11
Limb Fracture	10	10
Foreign Body Reaction	10	10
Hip Fracture	10	10
Implant Pain	10	10
Discomfort	9	9
Necrosis	8	8
Osteopenia/ Osteoporosis	8	8
Hypersensitivity/Allergic reaction	8	8
Local Reaction	8	8
Fluid Discharge	8	8
Unspecified Tissue Injury	7	8
Wound Dehiscence	7	7
No Information	6	6
Extraskeletal ossification	5	5
Physical Asymmetry	5	5
Inflammation	5	5
Swelling/ Edema	5	6
Sleep Dysfunction	5	5
Dyspnea	4	4
Cyst(s)	4	5
Bacterial Infection	4	4
Adhesion(s)	4	4
Scar Tissue	4	4
Post Operative Wound Infection	4	4
Unequal Limb Length	3	3
Joint effusion	3	3
Numbness	3	4
Hemorrhage/Blood Loss/Bleeding	3	3
Periprosthetic fracture	3	3
Nonunion/Delayed-union Bone Fracture	3	3