TPLC - Total Product Life Cycle

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Device	prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer
Definition	The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Product Code	NPJ
Regulation Number	888.3560
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	218	218
Break	195	195
Adverse Event Without Identified Device or Use Problem	122	122
Fracture	102	102
Loss of Osseointegration	47	47
Crack	27	27
Material Integrity Problem	26	26
Appropriate Term/Code Not Available	25	25
Material Deformation	24	24
Naturally Worn	22	22
Difficult to Insert	20	20
Degraded	16	16
Osseointegration Problem	16	16
Device Operates Differently Than Expected	15	15
Packaging Problem	14	14
Device Difficult to Setup or Prepare	13	13
Positioning Problem	13	13
Material Discolored	12	12
Device Dislodged or Dislocated	12	12
Malposition of Device	12	12
Device Slipped	11	11
Fitting Problem	11	11
Mechanical Problem	11	11
Scratched Material	11	11
Unstable	10	10
Loose or Intermittent Connection	9	9
Migration	9	9
Detachment Of Device Component	7	7
Loss of or Failure to Bond	7	7
Noise, Audible	6	6
Unintended Movement	5	5
Device Damaged by Another Device	5	5
Use of Device Problem	4	4
Corroded	3	3
Device Contamination with Chemical or Other Material	3	3
Device Contaminated During Manufacture or Shipping	3	3
Inadequacy of Device Shape and/or Size	3	3
Device Packaging Compromised	3	3
Failure To Adhere Or Bond	3	3
Material Fragmentation	3	3
Off-Label Use	3	3
Unexpected Therapeutic Results	2	2
Dent in Material	2	2
Migration or Expulsion of Device	2	2
Bent	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Decoupling	2	2
No Apparent Adverse Event	2	2
Sticking	2	2
Detachment of Device or Device Component	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	222	222
Pain	191	191
Injury	157	157
No Known Impact Or Consequence To Patient	114	114
Unspecified Infection	77	77
No Code Available	55	55
Inadequate Osseointegration	51	51
Insufficient Information	39	39
No Clinical Signs, Symptoms or Conditions	31	31
No Patient Involvement	27	27
Bone Fracture(s)	25	25
No Information	19	19
Ambulation Difficulties	17	17
Fall	12	12
Discomfort	11	11
Arthritis	11	11
Swelling	8	8
Joint Laxity	8	8
Loss of Range of Motion	7	7
Failure of Implant	6	6
Joint Disorder	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Joint Dislocation	4	4
Inflammation	4	4
Post Operative Wound Infection	4	4
Foreign Body In Patient	4	4
Reaction	4	4
Arthralgia	3	3
Patient Problem/Medical Problem	3	3
Fluid Discharge	3	3
Device Embedded In Tissue or Plaque	3	3
Limited Mobility Of The Implanted Joint	2	2
Cyst(s)	2	2
Hypersensitivity/Allergic reaction	2	2
Subluxation	2	2
Swelling/ Edema	2	2
Damage to Ligament(s)	2	2
Fungal Infection	1	1
Complaint, Ill-Defined	1	1
Rheumatoid Arthritis	1	1
Adhesion(s)	1	1
Osteopenia/ Osteoporosis	1	1
Erythema	1	1
Muscular Rigidity	1	1
Joint Swelling	1	1
Osteolysis	1	1
Impaired Healing	1	1
Unspecified Tissue Injury	1	1
Therapeutic Response, Decreased	1	1
Bacterial Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ConforMIS, Inc.	II	Oct-21-2015
2	Mako Surgical Corporation	II	Jun-01-2018
3	Mako Surgical Corporation	II	Mar-01-2016
4	Mako Surgical Corporation	II	Mar-04-2014
5	Stryker Howmedica Osteonics Corp.	II	Jan-11-2012