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	275	277
Fracture	247	253
Adverse Event Without Identified Device or Use Problem	207	216
Device Dislodged or Dislocated	138	141
Positioning Failure	72	72
Material Deformation	49	51
Separation Failure	47	47
Damaged Thread	45	45
Loosening of Implant Not Related to Bone-Ingrowth	38	41
Detachment of Device or Device Component	36	36
Naturally Worn	27	29
Difficult to Remove	21	22
Packaging Problem	20	20
Physical Resistance/Sticking	18	18
Migration	17	17
Difficult or Delayed Separation	16	16
Material Erosion	15	15
Insufficient Device Problem Information	15	16
Unstable	13	13
Material Twisted/Bent	12	12
Noise, Audible	11	11
Device Contaminated During Manufacture or Shipping	10	10
Mechanical Problem	10	10
Delivered as Unsterile Product	9	9
Off-Label Use	8	8
Malposition of Device	8	8
Unintended Movement	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Device-Device Incompatibility	7	7
Positioning Problem	6	6
Degraded	5	5
Peeled/Delaminated	5	5
Activation, Positioning or Separation Problem	5	5
Separation Problem	5	5
Tear, Rip or Hole in Device Packaging	4	4
Patient Device Interaction Problem	4	4
Loss of or Failure to Bond	4	4
Break	3	3
Mechanical Jam	3	3
Patient-Device Incompatibility	2	2
Flaked	2	2
Difficult or Delayed Positioning	2	2
Inadequacy of Device Shape and/or Size	1	1
Compatibility Problem	1	1
Defective Device	1	1
Use of Device Problem	1	1
Device Damaged by Another Device	1	1
Migration or Expulsion of Device	1	1
Device Damaged Prior to Use	1	1
Appropriate Device Problem Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	641	652
Joint Dislocation	150	153
Pain	134	139
No Known Impact Or Consequence To Patient	101	101
Failure of Implant	53	56
Insufficient Information	49	51
Bone Fracture(s)	40	40
Unspecified Infection	33	35
Ambulation or Postural Difficulties	33	34
Fall	23	25
Foreign Body In Patient	18	19
Hemorrhage/Blood Loss/Bleeding	15	15
Bursitis	14	14
Metal Related Pathology	13	13
No Consequences Or Impact To Patient	13	14
No Information	13	13
Osteolysis	12	12
No Patient Involvement	11	11
Joint Laxity	10	10
Inflammation	10	10
Aseptic loosening	10	10
Scar Tissue	9	9
Bacterial Infection	9	9
No Code Available	9	9
Swelling/ Edema	9	9
Impaired Healing	8	8
Unequal Limb Length	7	7
Wound Dehiscence	7	7
Loss of Range of Motion	6	6
Muscle/Tendon Damage	6	6
Subluxation	6	6
Joint Impingement	5	5
Hypersensitivity/Allergic reaction	4	4
Device Embedded In Tissue or Plaque	4	4
High metal ion levels	4	4
Osteopenia/ Osteoporosis	4	4
Periprosthetic fracture	4	4
Sleep Dysfunction	3	3
Patient Problem/Medical Problem	3	3
Thrombosis/Thrombus	3	3
Abscess	3	3
Anemia	3	3
Medical device site infection	3	3
Unspecified Tissue Injury	3	4
Tendinopathy	3	3
Sepsis	3	3
Pulmonary Embolism	3	3
Hypovolemia	2	2
Extraskeletal ossification	2	2
Radiolucent Lines	2	2