TPLC - Total Product Life Cycle

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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	3983	4101
Device Dislodged or Dislocated	622	649
Naturally Worn	524	554
Material Erosion	431	441
Tear, Rip or Hole in Device Packaging	403	404
Fracture	328	338
Osseointegration Problem	279	280
Insufficient Information	247	250
Manufacturing, Packaging or Shipping Problem	220	220
Packaging Problem	198	198
Loosening of Implant Not Related to Bone-Ingrowth	168	170
Patient Device Interaction Problem	154	154
Migration	150	156
Delivered as Unsterile Product	149	149
Noise, Audible	134	148
Use of Device Problem	118	119
Corroded	109	111
Difficult to Insert	96	98
Degraded	79	86
Biocompatibility	78	81
Appropriate Term/Code Not Available	66	67
Patient-Device Incompatibility	49	53
Detachment of Device or Device Component	41	41
Unstable	40	40
Device Contaminated During Manufacture or Shipping	40	42
Separation Failure	32	32
Inadequacy of Device Shape and/or Size	30	30
Difficult to Remove	29	29
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
Loss of or Failure to Bond	14	14
Material Disintegration	14	14
Break	13	13
No Apparent Adverse Event	13	13
Mechanical Problem	10	10
Physical Resistance/Sticking	10	10
Material Deformation	10	10
Improper or Incorrect Procedure or Method	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	2740	2825
Metal Related Pathology	1680	1734
Foreign Body Reaction	1338	1382
No Clinical Signs, Symptoms or Conditions	1265	1278
Unspecified Infection	699	718
Insufficient Information	694	718
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	687	706
Osteolysis	550	563
Hypersensitivity/Allergic reaction	545	567
Joint Dislocation	494	504
Swelling/ Edema	492	519
Failure of Implant	433	449
Unspecified Tissue Injury	414	444
Discomfort	396	420
Distress	362	387
Loss of Range of Motion	339	362
Joint Laxity	336	351
Ambulation Difficulties	329	352
Inadequate Osseointegration	297	298
Bone Fracture(s)	244	252
Deformity/ Disfigurement	221	230
Synovitis	200	216
Necrosis	200	214
Scar Tissue	188	204
Inflammation	177	189
Muscle/Tendon Damage	152	162
Fall	142	150
Adhesion(s)	135	145
Anxiety	135	145
Fatigue	122	133
Physical Asymmetry	100	110
Cyst(s)	93	98
Ossification	81	85
Muscular Rigidity	71	76
Depression	69	73
Numbness	59	66
Hemorrhage/Bleeding	47	51
Pocket Erosion	47	48
Osteopenia/ Osteoporosis	46	49
Bacterial Infection	39	42
Fluid Discharge	38	38
Unequal Limb Length	34	35
Local Reaction	34	35
Hematoma	33	34
Limb Fracture	33	35
Unspecified Musculoskeletal problem	32	34
Nerve Damage	31	35
Abscess	31	31
Memory Loss/Impairment	28	28
Thrombosis/Thrombus	25	28