TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Regulation Description	Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Product Code	KWA
Regulation Number	888.3330
Device Class	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3877	3995
Device Dislodged or Dislocated	612	639
Naturally Worn	513	543
Material Erosion	392	402
Fracture	311	321
Tear, Rip or Hole in Device Packaging	286	287
Osseointegration Problem	273	274
Insufficient Information	245	248
Manufacturing, Packaging or Shipping Problem	220	220
Packaging Problem	198	198
Loosening of Implant Not Related to Bone-Ingrowth	161	163
Patient Device Interaction Problem	154	154
Migration	147	153
Noise, Audible	128	142
Use of Device Problem	115	116
Corroded	109	111
Difficult to Insert	96	98
Delivered as Unsterile Product	89	89
Biocompatibility	78	81
Degraded	78	85
Appropriate Term/Code Not Available	66	67
Patient-Device Incompatibility	49	53
Device Contaminated During Manufacture or Shipping	40	42
Unstable	39	39
Detachment of Device or Device Component	37	37
Separation Failure	28	28
Difficult to Remove	26	26
Inadequacy of Device Shape and/or Size	25	25
Loss of Osseointegration	24	24
Malposition of Device	24	24
Off-Label Use	22	25
Positioning Failure	21	21
Device-Device Incompatibility	19	19
Material Integrity Problem	18	18
Material Disintegration	14	14
Loss of or Failure to Bond	13	13
Break	13	13
No Apparent Adverse Event	13	13
Physical Resistance/Sticking	10	10
Material Deformation	10	10
Improper or Incorrect Procedure or Method	9	9
Mechanical Problem	9	9
Unsealed Device Packaging	8	8
Unintended Movement	8	8
Migration or Expulsion of Device	8	8
Separation Problem	7	7
Inaccurate Information	7	7
Output Problem	7	8
Positioning Problem	6	7
Mechanical Jam	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2681	2766
Metal Related Pathology	1606	1660
Foreign Body Reaction	1302	1346
No Clinical Signs, Symptoms or Conditions	1138	1151
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	687	706
Unspecified Infection	683	702
Insufficient Information	682	706
Osteolysis	540	553
Hypersensitivity/Allergic reaction	531	553
Joint Dislocation	485	495
Swelling/ Edema	484	511
Failure of Implant	431	447
Unspecified Tissue Injury	407	437
Discomfort	393	417
Distress	360	385
Joint Laxity	330	345
Loss of Range of Motion	326	349
Ambulation Difficulties	321	344
Inadequate Osseointegration	291	292
Bone Fracture(s)	240	248
Deformity/ Disfigurement	221	230
Synovitis	194	210
Necrosis	194	208
Scar Tissue	182	198
Inflammation	174	186
Muscle/Tendon Damage	149	159
Fall	137	145
Adhesion(s)	135	145
Anxiety	132	142
Fatigue	116	126
Physical Asymmetry	96	106
Cyst(s)	91	96
Ossification	77	81
Muscular Rigidity	70	75
Depression	68	71
Numbness	59	66
Pocket Erosion	47	48
Osteopenia/ Osteoporosis	46	49
Hemorrhage/Bleeding	41	45
Local Reaction	34	35
Limb Fracture	33	35
Unspecified Musculoskeletal problem	32	34
Fluid Discharge	32	32
Nerve Damage	31	35
Unequal Limb Length	31	32
Hematoma	30	31
Bacterial Infection	30	33
Memory Loss/Impairment	28	28
Thrombosis/Thrombus	25	28
Abscess	24	24