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	1407	1407
Fracture	647	647
Adverse Event Without Identified Device or Use Problem	334	352
Loosening of Implant Not Related to Bone-Ingrowth	210	210
Detachment of Device or Device Component	187	187
Insufficient Information	166	166
Crack	142	142
Naturally Worn	138	161
Unstable	98	98
Loose or Intermittent Connection	72	72
Material Deformation	70	70
Connection Problem	62	62
Loss of Osseointegration	60	60
Material Fragmentation	52	52
Positioning Failure	51	51
Device Dislodged or Dislocated	48	48
Appropriate Term/Code Not Available	45	45
Component Missing	39	39
Defective Device	39	39
Mechanical Jam	39	39
Mechanical Problem	37	37
Dull, Blunt	37	37
Material Separation	28	28
Difficult to Insert	26	26
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
Noise, Audible	9	9
Failure to Align	9	9
Positioning Problem	8	8
Use of Device Problem	7	7
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	2529	2552
Pain	300	318
Insufficient Information	183	183
No Known Impact Or Consequence To Patient	182	182
Unspecified Infection	177	177
Failure of Implant	168	173
No Patient Involvement	161	161
Ambulation Difficulties	96	96
No Consequences Or Impact To Patient	86	86
No Information	77	77
Swelling/ Edema	76	76
No Code Available	71	71
Joint Laxity	68	68
Loss of Range of Motion	59	59
Joint Dislocation	38	38
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
Implant Pain	7	7
Muscular Rigidity	7	7
Inadequate Osseointegration	7	7
Discomfort	7	7
Joint Disorder	7	7
Laceration(s)	7	7
Thrombosis/Thrombus	6	6
Swelling	6	6
Subluxation	6	6
Osteopenia/ Osteoporosis	5	5
Adhesion(s)	5	5
Fall	5	5
Cellulitis	4	4
Unspecified Tissue Injury	4	4
Tissue Breakdown	4	4
Fluid Discharge	4	4
Blister	3	3
Bacterial Infection	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