TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1418	1418
Fracture	681	681
Adverse Event Without Identified Device or Use Problem	338	356
Loosening of Implant Not Related to Bone-Ingrowth	210	210
Detachment of Device or Device Component	198	198
Insufficient Information	169	169
Naturally Worn	142	165
Crack	142	142
Unstable	99	99
Loose or Intermittent Connection	72	72
Material Deformation	72	72
Loss of Osseointegration	63	63
Connection Problem	62	62
Material Fragmentation	54	54
Positioning Failure	53	53
Device Dislodged or Dislocated	50	50
Appropriate Term/Code Not Available	45	45
Component Missing	39	39
Defective Device	39	39
Mechanical Jam	39	39
Mechanical Problem	38	38
Dull, Blunt	37	37
Difficult to Insert	31	31
Material Separation	28	28
Incomplete or Inadequate Connection	22	22
Patient Device Interaction Problem	22	22
Migration	21	21
Device Contamination with Chemical or Other Material	21	21
Material Twisted/Bent	21	21
Unintended Movement	19	19
Patient-Device Incompatibility	16	16
Material Integrity Problem	16	21
Physical Resistance/Sticking	15	15
Malposition of Device	15	15
Device Markings/Labelling Problem	14	14
Loss of or Failure to Bond	14	14
Degraded	14	14
Separation Failure	13	13
Mechanics Altered	13	13
Device Reprocessing Problem	12	12
Corroded	12	12
Positioning Problem	10	10
Noise, Audible	9	9
Failure to Align	9	9
Use of Device Problem	8	8
Improper or Incorrect Procedure or Method	7	7
Premature Separation	7	7
Device-Device Incompatibility	6	6
Material Discolored	6	6
Flaked	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2588	2611
Pain	302	320
Insufficient Information	195	195
No Known Impact Or Consequence To Patient	182	182
Unspecified Infection	181	181
Failure of Implant	169	174
No Patient Involvement	161	161
Ambulation Difficulties	96	96
No Consequences Or Impact To Patient	86	86
Swelling/ Edema	77	77
No Information	77	77
No Code Available	71	71
Joint Laxity	68	68
Loss of Range of Motion	60	60
Joint Dislocation	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Bone Fracture(s)	34	34
Synovitis	28	28
Foreign Body In Patient	26	26
Injury	23	23
Osteolysis	17	17
Hypersensitivity/Allergic reaction	14	14
Ossification	14	14
Scar Tissue	13	13
Metal Related Pathology	11	11
Post Operative Wound Infection	11	11
Arthritis	10	10
Inflammation	10	10
Device Embedded In Tissue or Plaque	9	9
Not Applicable	8	8
Joint Disorder	7	7
Inadequate Osseointegration	7	7
Laceration(s)	7	7
Implant Pain	7	7
Discomfort	7	7
Muscular Rigidity	7	7
Subluxation	6	6
Swelling	6	6
Thrombosis/Thrombus	6	6
Osteopenia/ Osteoporosis	5	5
Adhesion(s)	5	5
Fall	5	5
Cellulitis	4	4
Fluid Discharge	4	4
Tissue Breakdown	4	4
Unspecified Tissue Injury	4	4
Pulmonary Embolism	3	3
Blister	3	3
Perforation	3	3
Cyst(s)	3	3

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