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	501	501
Fracture	269	269
Adverse Event Without Identified Device or Use Problem	197	197
Device Dislodged or Dislocated	156	157
Insufficient Information	132	132
Positioning Failure	92	92
Difficult To Position	62	62
Component or Accessory Incompatibility	47	47
Packaging Problem	42	42
Material Deformation	41	41
Separation Failure	40	40
Device Contaminated During Manufacture or Shipping	38	38
Detachment of Device or Device Component	38	38
Fitting Problem	36	36
Difficult to Remove	30	30
Device-Device Incompatibility	29	29
Migration or Expulsion of Device	29	29
Loosening of Implant Not Related to Bone-Ingrowth	25	25
Positioning Problem	19	19
Break	18	18
Unstable	16	16
Naturally Worn	16	16
Physical Resistance/Sticking	15	15
Noise, Audible	15	15
Material Erosion	14	14
Delivered as Unsterile Product	14	14
Difficult or Delayed Separation	13	13
Tear, Rip or Hole in Device Packaging	12	12
Migration	11	11
Device Packaging Compromised	11	11
Mechanical Problem	11	11
Appropriate Term/Code Not Available	10	10
Difficult or Delayed Positioning	10	10
Unsealed Device Packaging	9	9
Malposition of Device	9	9
Unintended Movement	7	7
Degraded	6	6
Material Twisted/Bent	5	5
Corroded	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Loss of or Failure to Bond	5	5
Peeled/Delaminated	5	5
Device Operates Differently Than Expected	5	5
Activation, Positioning or Separation Problem	5	5
Disassembly	4	4
Patient Device Interaction Problem	4	4
Off-Label Use	4	4
Device Contamination with Chemical or Other Material	3	3
Defective Device	3	3
Accessory Incompatible	3	3

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	329	329
No Information	240	240
Pain	177	177
Joint Dislocation	152	153
No Consequences Or Impact To Patient	122	123
Unspecified Infection	94	94
No Code Available	93	93
No Patient Involvement	55	55
Bone Fracture(s)	51	51
Ambulation Difficulties	44	44
Failure of Implant	38	38
Fall	32	32
Insufficient Information	32	32
Foreign Body In Patient	24	24
Blood Loss	19	19
Device Embedded In Tissue or Plaque	18	18
Loss of Range of Motion	17	17
Wound Dehiscence	16	16
Bacterial Infection	16	16
Impaired Healing	14	14
Hemorrhage/Bleeding	14	14
Hematoma	14	14
Tissue Damage	11	11
Limited Mobility Of The Implanted Joint	11	11
Metal Related Pathology	10	10
Swelling	9	9
Subluxation	8	8
Osteolysis	8	8
Discomfort	8	8
Patient Problem/Medical Problem	8	8
Inflammation	8	8
Death	7	7
Scar Tissue	7	7
Hip Fracture	7	7
Swelling/ Edema	6	6
Unequal Limb Length	6	6
Osteopenia/ Osteoporosis	5	5
Ossification	5	5
Reaction	5	5
Post Operative Wound Infection	5	5
Low Blood Pressure/ Hypotension	4	4
Sleep Dysfunction	4	4
Weakness	4	4
Cellulitis	4	4
Local Reaction	3	3
Thrombosis/Thrombus	3	3
Anemia	3	3
Pulmonary Embolism	3	3
Staphylococcus Aureus	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Jun-19-2014