TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
Product Code	HRY
Regulation Number	888.3530
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1451	1451
Fracture	561	561
Adverse Event Without Identified Device or Use Problem	399	417
Insufficient Information	226	226
Loosening of Implant Not Related to Bone-Ingrowth	212	212
Detachment of Device or Device Component	160	160
Naturally Worn	156	179
Crack	142	142
Unstable	132	132
Loose or Intermittent Connection	80	80
Material Deformation	70	70
Connection Problem	64	64
Loss of Osseointegration	61	61
Device Dislodged or Dislocated	54	54
Appropriate Term/Code Not Available	53	53
Positioning Failure	48	48
Material Fragmentation	46	46
Component Missing	40	40
Mechanical Jam	39	39
Defective Device	39	39
Dull, Blunt	37	37
Mechanical Problem	37	37
Difficult to Insert	33	33
Migration	28	28
Material Separation	28	28
Patient Device Interaction Problem	24	24
Loss of or Failure to Bond	23	23
Incomplete or Inadequate Connection	22	22
Material Twisted/Bent	22	22
Device Contamination with Chemical or Other Material	21	21
Malposition of Device	21	21
Unintended Movement	20	20
Noise, Audible	20	20
Material Integrity Problem	17	22
Patient-Device Incompatibility	16	16
Physical Resistance/Sticking	15	15
Device Markings/Labelling Problem	14	14
Device-Device Incompatibility	14	14
Mechanics Altered	13	13
Degraded	13	13
Device Reprocessing Problem	12	12
Corroded	11	11
Separation Failure	11	11
Contamination /Decontamination Problem	9	9
Improper or Incorrect Procedure or Method	9	9
Flaked	8	8
Use of Device Problem	8	8
Failure to Align	8	8
Osseointegration Problem	7	7
Inadequacy of Device Shape and/or Size	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2387	2410
Pain	371	389
Unspecified Infection	200	200
No Known Impact Or Consequence To Patient	200	200
Insufficient Information	166	166
No Consequences Or Impact To Patient	165	165
Failure of Implant	165	170
No Patient Involvement	164	164
No Information	150	150
No Code Available	130	130
Ambulation Difficulties	100	100
Loss of Range of Motion	78	78
Swelling/ Edema	74	74
Joint Laxity	66	66
Injury	60	60
Joint Dislocation	44	44
Bone Fracture(s)	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Synovitis	27	27
Osteolysis	25	25
Foreign Body In Patient	24	24
Not Applicable	21	21
Inflammation	17	17
Inadequate Osseointegration	17	17
Swelling	17	17
Muscular Rigidity	16	16
Ossification	14	14
Scar Tissue	13	13
Adhesion(s)	13	13
Metal Related Pathology	12	12
Fall	12	12
Discomfort	12	12
Hypersensitivity/Allergic reaction	12	12
Post Operative Wound Infection	11	11
Arthritis	10	10
Joint Disorder	9	9
Device Embedded In Tissue or Plaque	9	9
Reaction	7	7
Limited Mobility Of The Implanted Joint	7	7
Laceration(s)	6	6
Subluxation	6	6
Hemorrhage/Bleeding	6	6
Thrombosis/Thrombus	6	6
Implant Pain	6	6
Fatigue	6	6
Osteopenia/ Osteoporosis	5	5
Cyst(s)	5	5
Unspecified Tissue Injury	5	5
Cellulitis	4	4
Tissue Breakdown	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Sep-22-2021
2	Biomet, Inc.	II	Jan-26-2023
3	Biomet, Inc.	II	Dec-17-2020
4	Biomet, Inc.	II	May-28-2020
5	Exactech, Inc.	II	Oct-04-2021
6	MicroPort Orthopedics Inc.	II	Jul-01-2024
7	MicroPort Orthopedics Inc.	II	Nov-22-2022