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	1433	1438
Fracture	727	735
Adverse Event Without Identified Device or Use Problem	343	370
Detachment of Device or Device Component	212	213
Loosening of Implant Not Related to Bone-Ingrowth	211	213
Insufficient Information	183	183
Naturally Worn	148	173
Crack	143	144
Unstable	109	109
Material Deformation	75	76
Loose or Intermittent Connection	72	73
Loss of Osseointegration	63	63
Connection Problem	62	63
Positioning Failure	58	59
Material Fragmentation	55	55
Device Dislodged or Dislocated	52	53
Appropriate Term/Code Not Available	45	48
Mechanical Jam	39	39
Component Missing	39	39
Defective Device	39	39
Mechanical Problem	38	38
Dull, Blunt	37	37
Difficult to Insert	33	33
Material Separation	28	28
Incomplete or Inadequate Connection	22	22
Patient Device Interaction Problem	22	22
Migration	21	24
Device Contamination with Chemical or Other Material	21	21
Material Twisted/Bent	21	21
Unintended Movement	19	19
Physical Resistance/Sticking	16	16
Patient-Device Incompatibility	16	16
Material Integrity Problem	16	21
Malposition of Device	15	15
Loss of or Failure to Bond	14	14
Mechanics Altered	14	14
Device Markings/Labelling Problem	14	14
Degraded	14	14
Separation Failure	13	13
Device Reprocessing Problem	12	12
Corroded	12	12
Positioning Problem	11	11
Noise, Audible	9	12
Failure to Align	9	9
Use of Device Problem	8	8
Premature Separation	7	7
Improper or Incorrect Procedure or Method	7	7
Flaked	7	7
Peeled/Delaminated	6	6
Material Discolored	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2666	2703
Pain	305	327
Insufficient Information	218	220
Unspecified Infection	194	194
No Known Impact Or Consequence To Patient	182	182
Failure of Implant	168	175
No Patient Involvement	161	161
Ambulation Difficulties	95	95
No Consequences Or Impact To Patient	86	86
No Information	77	77
Swelling/ Edema	76	77
No Code Available	71	71
Joint Laxity	70	71
Loss of Range of Motion	59	60
Joint Dislocation	38	40
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	15	15
Ossification	14	15
Scar Tissue	13	17
Post Operative Wound Infection	11	11
Inflammation	10	10
Metal Related Pathology	10	11
Arthritis	10	10
Device Embedded In Tissue or Plaque	9	9
Not Applicable	8	8
Discomfort	8	10
Implant Pain	7	7
Joint Disorder	7	7
Muscular Rigidity	7	7
Laceration(s)	7	7
Inadequate Osseointegration	6	6
Thrombosis/Thrombus	6	6
Swelling	6	6
Subluxation	6	6
Adhesion(s)	5	5
Osteopenia/ Osteoporosis	5	7
Fall	5	5
Unspecified Tissue Injury	4	4
Tissue Breakdown	4	4
Pulmonary Embolism	4	4
Fluid Discharge	4	4
Perforation	3	4
Fibrosis	3	4
Blister	3	3
Bacterial Infection	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