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	233	235
Fracture	218	224
Adverse Event Without Identified Device or Use Problem	178	187
Device Dislodged or Dislocated	126	129
Material Deformation	46	48
Damaged Thread	44	44
Separation Failure	41	41
Positioning Failure	36	36
Loosening of Implant Not Related to Bone-Ingrowth	31	34
Naturally Worn	24	26
Detachment of Device or Device Component	21	21
Difficult to Remove	19	20
Packaging Problem	18	18
Physical Resistance/Sticking	17	17
Migration	15	15
Material Erosion	15	15
Insufficient Device Problem Information	14	15
Difficult or Delayed Separation	12	12
Material Twisted/Bent	12	12
Unstable	11	11
Noise, Audible	10	10
Mechanical Problem	9	9
Off-Label Use	8	8
Malposition of Device	8	8
Device-Device Incompatibility	6	6
Unintended Movement	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Positioning Problem	5	5
Separation Problem	5	5
Activation, Positioning or Separation Problem	5	5
Degraded	4	4
Peeled/Delaminated	4	4
Tear, Rip or Hole in Device Packaging	4	4
Break	4	4
Loss of or Failure to Bond	4	4
Device Contaminated During Manufacture or Shipping	3	3
Patient Device Interaction Problem	2	2
Delivered as Unsterile Product	2	2
Patient-Device Incompatibility	2	2
Mechanical Jam	2	2
Material Fragmentation	1	1
Scratched Material	1	1
Use of Device Problem	1	1
Material Integrity Problem	1	1
Difficult or Delayed Positioning	1	1
Crack	1	1
Migration or Expulsion of Device	1	1
Inadequacy of Device Shape and/or Size	1	1
Compatibility Problem	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	628	639
Joint Dislocation	131	134
Pain	114	119
Failure of Implant	52	55
Insufficient Information	49	51
Ambulation or Postural Difficulties	33	34
Bone Fracture(s)	33	33
Unspecified Infection	26	28
Foreign Body In Patient	17	18
Fall	16	18
Hemorrhage/Blood Loss/Bleeding	15	15
Bursitis	14	14
Metal Related Pathology	13	13
Joint Laxity	9	9
Bacterial Infection	9	9
Scar Tissue	8	8
Swelling/ Edema	8	8
Osteolysis	8	8
Aseptic loosening	8	8
No Known Impact Or Consequence To Patient	7	7
Unequal Limb Length	7	7
Inflammation	7	7
Subluxation	6	6
Muscle/Tendon Damage	6	6
Joint Impingement	5	5
High metal ion levels	4	4
Osteopenia/ Osteoporosis	4	4
Impaired Healing	4	4
Loss of Range of Motion	4	4
Hypersensitivity/Allergic reaction	4	4
Pulmonary Embolism	3	3
Abscess	3	3
Sepsis	3	3
Sleep Dysfunction	3	3
No Consequences Or Impact To Patient	3	3
Thrombosis/Thrombus	3	3
Unspecified Tissue Injury	3	4
Medical device site infection	3	3
Tendinopathy	3	3
Periprosthetic fracture	3	3
Crepitus	2	2
Arthrofibrosis	2	2
Radiolucent Lines	2	2
Partial Hearing Loss	2	2
Weight Changes	2	2
No Patient Involvement	2	2
Loss of Vision	2	2
Muscle Weakness/Atrophy	2	2
Pneumonia	2	2
Necrosis	2	2