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	267	269
Fracture	214	220
Adverse Event Without Identified Device or Use Problem	179	188
Device Dislodged or Dislocated	124	127
Positioning Failure	68	68
Material Deformation	48	50
Separation Failure	44	44
Detachment of Device or Device Component	35	35
Loosening of Implant Not Related to Bone-Ingrowth	31	34
Naturally Worn	23	25
Difficult to Remove	21	22
Packaging Problem	19	19
Migration	17	17
Physical Resistance/Sticking	17	17
Material Erosion	15	15
Insufficient Information	14	15
Difficult or Delayed Separation	14	14
Unstable	13	13
Noise, Audible	11	11
Material Twisted/Bent	11	11
Device Contaminated During Manufacture or Shipping	10	10
Mechanical Problem	10	10
Off-Label Use	8	8
Malposition of Device	8	8
Delivered as Unsterile Product	8	8
Unintended Movement	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Peeled/Delaminated	5	5
Activation, Positioning or Separation Problem	5	5
Positioning Problem	5	5
Separation Problem	5	5
Device-Device Incompatibility	5	5
Degraded	5	5
Break	5	5
Loss of or Failure to Bond	4	4
Patient Device Interaction Problem	4	4
Tear, Rip or Hole in Device Packaging	3	3
Difficult or Delayed Positioning	2	2
Flaked	2	2
Mechanical Jam	2	2
Use of Device Problem	1	1
Component Missing	1	1
Device Damaged by Another Device	1	1
Migration or Expulsion of Device	1	1
Material Fragmentation	1	1
Scratched Material	1	1
Compatibility Problem	1	1
Material Integrity Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	584	595
Joint Dislocation	129	132
Pain	110	115
No Known Impact Or Consequence To Patient	101	101
Failure of Implant	52	55
Insufficient Information	44	46
Bone Fracture(s)	40	40
Unspecified Infection	33	35
Ambulation Difficulties	28	29
Fall	23	25
Foreign Body In Patient	18	19
Hemorrhage/Bleeding	15	15
No Consequences Or Impact To Patient	13	14
No Information	13	13
No Patient Involvement	11	11
Metal Related Pathology	11	11
Inflammation	10	10
No Code Available	9	9
Bacterial Infection	8	8
Swelling/ Edema	8	8
Osteolysis	8	8
Impaired Healing	8	8
Scar Tissue	7	7
Unequal Limb Length	7	7
Subluxation	6	6
Joint Laxity	6	6
Wound Dehiscence	6	6
Loss of Range of Motion	6	6
Muscle/Tendon Damage	5	5
Device Embedded In Tissue or Plaque	4	4
Osteopenia/ Osteoporosis	4	4
Hypersensitivity/Allergic reaction	3	3
Pulmonary Embolism	3	3
Anemia	3	3
Unspecified Tissue Injury	3	4
Patient Problem/Medical Problem	3	3
Sleep Dysfunction	3	3
Thrombosis/Thrombus	3	3
Pneumonia	2	2
Partial Hearing Loss	2	2
Discomfort	2	2
Nerve Damage	2	2
Neck Stiffness	2	2
Erythema	2	2
Loss of Vision	2	2
Cellulitis	2	2
Cardiac Arrest	2	2
Ossification	2	2
Low Blood Pressure/ Hypotension	2	2
Blood Loss	2	2