TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, ankle, semi-constrained, cemented, metal/polymer
Product Code	HSN
Regulation Number	888.3110
Device Class	2

Premarket Reviews
Manufacturer	Decision
EXACTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES SAS
	SUBSTANTIALLY EQUIVALENT	4
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KINOS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	5
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	3
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	2
WRIGHT MEDICAL TECHNOLOGY, INC (STRYKER)
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1416	1416
Osseointegration Problem	670	670
Insufficient Information	570	570
Migration	439	439
Loss of Osseointegration	94	94
Break	63	63
Fracture	56	56
Loosening of Implant Not Related to Bone-Ingrowth	55	55
Appropriate Term/Code Not Available	34	34
Naturally Worn	31	31
Malposition of Device	28	28
Device Dislodged or Dislocated	28	28
Inadequacy of Device Shape and/or Size	20	20
Use of Device Problem	20	20
Unintended Movement	16	16
Failure to Osseointegrate	15	15
Device Difficult to Setup or Prepare	13	13
Unstable	12	12
Detachment of Device or Device Component	12	12
Positioning Failure	11	11
Patient Device Interaction Problem	10	10
Patient-Device Incompatibility	9	9
Off-Label Use	8	8
Defective Device	8	8
Loss of or Failure to Bond	6	6
Mechanical Jam	6	6
Inaccurate Information	6	6
Component Missing	6	6
Improper or Incorrect Procedure or Method	5	5
Device Handling Problem	4	4
Material Deformation	4	4
Material Fragmentation	4	4
Positioning Problem	4	4
Material Discolored	3	3
Degraded	3	3
Device Damaged by Another Device	2	2
Shipping Damage or Problem	2	2
Material Separation	2	2
No Apparent Adverse Event	2	2
Nonstandard Device	2	2
Device Markings/Labelling Problem	2	2
Device-Device Incompatibility	2	2
Material Twisted/Bent	1	1
Failure to Align	1	1
Difficult to Insert	1	1
Difficult or Delayed Positioning	1	1
Misassembly by Users	1	1
Contamination /Decontamination Problem	1	1
Residue After Decontamination	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	995	995
Inadequate Osseointegration	784	784
Implant Pain	486	486
Cyst(s)	454	454
Unspecified Infection	302	302
Failure of Implant	159	159
No Clinical Signs, Symptoms or Conditions	154	154
Pain	142	142
Swelling/ Edema	133	133
Loss of Range of Motion	110	110
Osteolysis	109	109
Bone Fracture(s)	99	99
Injury	87	87
Limb Fracture	78	78
Wound Dehiscence	64	64
Patient Problem/Medical Problem	57	57
Ambulation Difficulties	45	45
Post Operative Wound Infection	45	45
Impaired Healing	35	35
Ossification	32	32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	30	30
Bacterial Infection	26	26
Discomfort	25	25
Deformity/ Disfigurement	24	24
Joint Laxity	23	23
Subluxation	22	22
Arthritis	22	22
Numbness	18	18
Fluid Discharge	17	17
Joint Dislocation	17	17
Inflammation	16	16
No Code Available	14	14
Nerve Damage	13	13
Erythema	12	12
Fall	12	12
Osteopenia/ Osteoporosis	11	11
Malunion of Bone	10	10
Unspecified Tissue Injury	8	8
Necrosis	8	8
Rheumatoid Arthritis	8	8
Purulent Discharge	7	7
No Information	7	7
Arthralgia	7	7
Foreign Body In Patient	6	6
Ankylosis	6	6
Damage to Ligament(s)	6	6
Foreign Body Reaction	5	5
Neuropathy	5	5
No Known Impact Or Consequence To Patient	4	4
Fibrosis	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Exactech, Inc.	II	Jan-18-2024
2	Exactech, Inc.	II	Oct-04-2021
3	Exactech, Inc.	II	Aug-31-2020
4	Wright Medical Technology Inc	II	Dec-01-2021
5	Wright Medical Technology Inc	II	May-07-2020
6	Wright Medical Technology, Inc.	II	Apr-04-2024
7	Wright Medical Technology, Inc.	II	Jul-07-2023
8	Wright Medical Technology, Inc.	II	Oct-27-2022
9	Wright Medical Technology, Inc.	II	Jun-27-2022