TPLC - Total Product Life Cycle

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Device	prosthesis, ankle, semi-constrained, cemented, metal/polymer
Regulation Description	Ankle joint metal/polymer semi-constrained cemented prosthesis.
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	6
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	1570	1570
Osseointegration Problem	789	789
Insufficient Information	699	699
Migration	469	469
Loss of Osseointegration	101	101
Break	67	67
Fracture	65	65
Loosening of Implant Not Related to Bone-Ingrowth	65	65
Naturally Worn	40	40
Appropriate Term/Code Not Available	35	35
Malposition of Device	33	33
Device Dislodged or Dislocated	33	33
Inadequacy of Device Shape and/or Size	22	22
Unintended Movement	21	21
Unstable	20	20
Use of Device Problem	20	20
Failure to Osseointegrate	15	15
Device Difficult to Setup or Prepare	13	13
Detachment of Device or Device Component	12	12
Positioning Failure	12	12
Biocompatibility	10	10
Patient-Device Incompatibility	10	10
Patient Device Interaction Problem	10	10
Off-Label Use	9	9
Defective Device	8	8
Component Missing	7	7
Inaccurate Information	6	6
Mechanical Jam	6	6
Loss of or Failure to Bond	6	6
Material Deformation	5	5
Improper or Incorrect Procedure or Method	5	5
Material Fragmentation	4	4
Device Handling Problem	4	4
Positioning Problem	4	4
Material Discolored	3	3
Degraded	3	3
Shipping Damage or Problem	2	2
Device Damaged by Another Device	2	2
Material Separation	2	2
Manufacturing, Packaging or Shipping Problem	2	2
No Apparent Adverse Event	2	2
Device Markings/Labelling Problem	2	2
Crack	2	2
Nonstandard Device	2	2
Device-Device Incompatibility	2	2
Difficult to Insert	1	1
Contamination /Decontamination Problem	1	1
Failure to Align	1	1
Material Twisted/Bent	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1141	1141
Inadequate Osseointegration	905	905
Implant Pain	555	555
Cyst(s)	528	528
Unspecified Infection	349	349
Pain	181	181
Failure of Implant	172	172
No Clinical Signs, Symptoms or Conditions	157	157
Swelling/ Edema	146	146
Loss of Range of Motion	129	129
Osteolysis	122	122
Bone Fracture(s)	117	117
Injury	87	87
Limb Fracture	83	83
Wound Dehiscence	79	79
Ambulation Difficulties	66	66
Patient Problem/Medical Problem	57	57
Post Operative Wound Infection	51	51
Discomfort	39	39
Impaired Healing	37	37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	35
Subluxation	34	34
Joint Laxity	32	32
Ossification	32	32
Bacterial Infection	32	32
Deformity/ Disfigurement	26	26
Arthritis	22	22
Joint Dislocation	18	18
Numbness	18	18
Fluid Discharge	17	17
Inflammation	17	17
Nerve Damage	16	16
Erythema	15	15
No Code Available	14	14
Scar Tissue	13	13
Fall	12	12
Osteopenia/ Osteoporosis	11	11
Malunion of Bone	10	10
Rheumatoid Arthritis	9	9
Foreign Body Reaction	8	8
Necrosis	8	8
Unspecified Tissue Injury	8	8
Purulent Discharge	7	7
No Information	7	7
Fever	7	7
Arthralgia	7	7
Capsular Contracture	6	6
Ankylosis	6	6
Damage to Ligament(s)	6	6
Foreign Body In Patient	6	6

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