TPLC - Total Product Life Cycle

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Device	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
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	297	297
Adverse Event Without Identified Device or Use Problem	174	174
Fracture	158	158
Device Dislodged or Dislocated	97	98
Positioning Failure	91	91
Material Deformation	36	36
Detachment of Device or Device Component	33	33
Separation Failure	31	31
Device Contaminated During Manufacture or Shipping	28	28
Insufficient Information	27	27
Loosening of Implant Not Related to Bone-Ingrowth	25	25
Packaging Problem	22	22
Difficult to Remove	21	21
Naturally Worn	16	16
Physical Resistance/Sticking	15	15
Unstable	14	14
Material Erosion	14	14
Noise, Audible	13	13
Difficult or Delayed Separation	13	13
Migration	11	11
Delivered as Unsterile Product	11	11
Mechanical Problem	10	10
Unintended Movement	7	7
Degraded	6	6
Positioning Problem	6	6
Break	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Material Twisted/Bent	5	5
Peeled/Delaminated	5	5
Tear, Rip or Hole in Device Packaging	5	5
Loss of or Failure to Bond	5	5
Activation, Positioning or Separation Problem	5	5
Patient Device Interaction Problem	4	4
Difficult or Delayed Positioning	4	4
Malposition of Device	4	4
Off-Label Use	4	4
Migration or Expulsion of Device	4	4
Device-Device Incompatibility	4	4
Separation Problem	3	3
Unsealed Device Packaging	2	2
Material Disintegration	2	2
Device Damaged by Another Device	2	2
Compatibility Problem	2	2
Flaked	2	2
Material Integrity Problem	1	1
Defective Device	1	1
Scratched Material	1	1
Material Fragmentation	1	1
Shipping Damage or Problem	1	1
Device Markings/Labelling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	418	418
No Known Impact Or Consequence To Patient	164	164
Pain	112	112
Joint Dislocation	96	97
Unspecified Infection	50	50
No Information	48	48
No Consequences Or Impact To Patient	39	40
Failure of Implant	38	38
No Code Available	36	36
Insufficient Information	32	32
No Patient Involvement	31	31
Bone Fracture(s)	30	30
Fall	28	28
Ambulation Difficulties	24	24
Wound Dehiscence	15	15
Foreign Body In Patient	15	15
Hemorrhage/Bleeding	14	14
Loss of Range of Motion	12	12
Metal Related Pathology	10	10
Bacterial Infection	10	10
Impaired Healing	10	10
Inflammation	8	8
Tissue Damage	8	8
Patient Problem/Medical Problem	8	8
Osteolysis	8	8
Limited Mobility Of The Implanted Joint	7	7
Subluxation	7	7
Swelling/ Edema	6	6
Unequal Limb Length	6	6
Blood Loss	5	5
Osteopenia/ Osteoporosis	5	5
Ossification	5	5
Death	5	5
Scar Tissue	5	5
Low Blood Pressure/ Hypotension	4	4
Device Embedded In Tissue or Plaque	4	4
Hematoma	3	3
Anemia	3	3
Local Reaction	3	3
Cellulitis	3	3
Unspecified Tissue Injury	3	3
Host-Tissue Reaction	3	3
Pulmonary Embolism	3	3
Thrombosis/Thrombus	3	3
Sleep Dysfunction	3	3
Neck Stiffness	2	2
Embolism	2	2
Muscle/Tendon Damage	2	2
Pneumonia	2	2
Hypovolemia	2	2