TPLC - Total Product Life Cycle

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Device	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
Regulation Description	Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Definition	For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Product Code	PBI
Regulation Number	888.3310
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Insert	249	249
Fracture	169	169
Adverse Event Without Identified Device or Use Problem	149	149
Device Dislodged or Dislocated	102	103
Positioning Failure	64	64
Material Deformation	46	46
Separation Failure	36	36
Loosening of Implant Not Related to Bone-Ingrowth	28	28
Detachment of Device or Device Component	27	27
Difficult to Remove	20	20
Naturally Worn	17	17
Packaging Problem	16	16
Physical Resistance/Sticking	15	15
Material Erosion	14	14
Difficult or Delayed Separation	13	13
Unstable	12	12
Device Contaminated During Manufacture or Shipping	10	10
Mechanical Problem	10	10
Insufficient Information	10	10
Migration	9	9
Noise, Audible	8	8
Delivered as Unsterile Product	8	8
Off-Label Use	8	8
Unintended Movement	7	7
Material Twisted/Bent	7	7
Manufacturing, Packaging or Shipping Problem	5	5
Degraded	5	5
Break	5	5
Activation, Positioning or Separation Problem	5	5
Positioning Problem	4	4
Patient Device Interaction Problem	4	4
Malposition of Device	4	4
Separation Problem	4	4
Device-Device Incompatibility	4	4
Loss of or Failure to Bond	4	4
Peeled/Delaminated	3	3
Tear, Rip or Hole in Device Packaging	3	3
Difficult or Delayed Positioning	2	2
Flaked	2	2
Defective Device	1	1
Material Integrity Problem	1	1
Unsealed Device Packaging	1	1
Scratched Material	1	1
Material Fragmentation	1	1
Patient-Device Incompatibility	1	1
Use of Device Problem	1	1
Component Missing	1	1
Device Damaged Prior to Use	1	1
Device Damaged by Another Device	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	488	488
Joint Dislocation	105	106
No Known Impact Or Consequence To Patient	101	101
Pain	90	90
Failure of Implant	46	46
Insufficient Information	35	35
Bone Fracture(s)	33	33
Unspecified Infection	32	32
Ambulation Difficulties	24	24
Fall	22	22
Foreign Body In Patient	16	16
Hemorrhage/Bleeding	14	14
No Consequences Or Impact To Patient	13	14
No Information	13	13
No Patient Involvement	11	11
Metal Related Pathology	10	10
No Code Available	9	9
Inflammation	9	9
Impaired Healing	8	8
Bacterial Infection	8	8
Osteolysis	8	8
Swelling/ Edema	7	7
Unequal Limb Length	6	6
Loss of Range of Motion	6	6
Wound Dehiscence	6	6
Subluxation	5	5
Scar Tissue	5	5
Joint Laxity	4	4
Osteopenia/ Osteoporosis	4	4
Device Embedded In Tissue or Plaque	4	4
Unspecified Tissue Injury	3	3
Anemia	3	3
Muscle/Tendon Damage	3	3
Sleep Dysfunction	3	3
Pulmonary Embolism	3	3
Patient Problem/Medical Problem	3	3
Thrombosis/Thrombus	3	3
Neck Stiffness	2	2
Pneumonia	2	2
Partial Hearing Loss	2	2
Arrhythmia	2	2
Loss of Vision	2	2
Weight Changes	2	2
Stroke/CVA	2	2
Hypersensitivity/Allergic reaction	2	2
Fatigue	2	2
Sepsis	2	2
Discomfort	2	2
Low Blood Pressure/ Hypotension	2	2
Hypovolemia	2	2