TPLC - Total Product Life Cycle

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Device	prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Description	Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Product Code	KWZ
Regulation Number	888.3310
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	538	542
Adverse Event Without Identified Device or Use Problem	315	320
Fracture	108	114
Device Contaminated During Manufacture or Shipping	68	68
Naturally Worn	57	57
Detachment of Device or Device Component	52	52
Unstable	36	36
Difficult to Insert	33	34
Insufficient Device Problem Information	19	19
Break	15	16
Packaging Problem	15	15
Off-Label Use	13	13
Noise, Audible	12	13
Loosening of Implant Not Related to Bone-Ingrowth	12	12
Scratched Material	12	12
Positioning Failure	11	11
Device-Device Incompatibility	11	11
Material Deformation	10	10
Unintended Movement	8	8
Material Erosion	7	7
Tear, Rip or Hole in Device Packaging	6	6
Migration	6	6
Mechanical Problem	6	6
Patient Device Interaction Problem	5	6
Contamination /Decontamination Problem	4	4
Difficult to Remove	3	3
Device Difficult to Setup or Prepare	3	3
Use of Device Problem	3	3
Separation Failure	3	3
Degraded	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Defective Device	2	2
Component Missing	2	2
Osseointegration Problem	2	6
Deformation Due to Compressive Stress	2	2
Improper or Incorrect Procedure or Method	2	2
Difficult to Open or Close	2	2
Malposition of Device	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Illegible Information	2	2
Loss of Osseointegration	1	1
Loss of or Failure to Bond	1	1
Mechanical Jam	1	1
Biocompatibility	1	1
Connection Problem	1	1
Unintended System Motion	1	1
Nonstandard Device	1	1
No Apparent Adverse Event	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Damaged Prior to Receipt by User	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	523	532
Insufficient Information	131	135
No Code Available	122	124
No Clinical Signs, Symptoms or Conditions	118	119
Pain	116	122
Unspecified Infection	112	118
Joint Laxity	92	94
No Patient Involvement	54	54
Failure of Implant	44	45
Fall	41	41
Ambulation or Postural Difficulties	36	37
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	28	29
No Known Impact Or Consequence To Patient	26	26
Injury	21	21
Osteolysis	18	18
Foreign Body Reaction	18	19
Bone Fracture(s)	18	19
No Consequences Or Impact To Patient	15	15
Loss of Range of Motion	13	14
Medical device site infection	13	13
No Information	12	12
Hematoma	12	12
Scar Tissue	9	10
Osteopenia/ Osteoporosis	9	9
Metal Related Pathology	8	9
Discomfort	7	7
Adhesion(s)	7	8
Inflammation	7	7
Limited Mobility Of The Implanted Joint	6	6
Necrosis	6	7
Weakness	6	6
Extraskeletal ossification	6	7
Unspecified Tissue Injury	6	7
Edema	6	6
Hemorrhage/Blood Loss/Bleeding	5	6
Unspecified Musculoskeletal problem	5	5
Muscle/Tendon Damage	5	5
Swelling/ Edema	5	5
Hypersensitivity/Allergic reaction	4	4
Aseptic loosening	4	8
Thrombosis	4	4
Fatigue	4	4
Anemia	4	4
Tissue Damage	4	4
Deformity/ Disfigurement	4	4
Not Applicable	4	4
Anxiety	3	3
Physical Asymmetry	3	3
Synovitis	3	3
Limb Fracture	3	3