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
WRIGHT MEDICAL TECHNOLOGY, INC. (STRYKER)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1693	1693
Osseointegration Problem	849	849
Insufficient Information	753	753
Migration	487	487
Loss of Osseointegration	104	104
Fracture	74	74
Break	72	72
Loosening of Implant Not Related to Bone-Ingrowth	67	67
Naturally Worn	45	45
Malposition of Device	38	38
Appropriate Term/Code Not Available	35	35
Device Dislodged or Dislocated	33	33
Inadequacy of Device Shape and/or Size	31	31
Unintended Movement	22	22
Unstable	21	21
Use of Device Problem	20	20
Failure to Osseointegrate	16	16
Positioning Failure	13	13
Device Difficult to Setup or Prepare	13	13
Detachment of Device or Device Component	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
Loss of or Failure to Bond	6	6
Mechanical Jam	6	6
Inaccurate Information	6	6
Improper or Incorrect Procedure or Method	5	5
Material Deformation	5	5
Positioning Problem	4	4
Material Fragmentation	4	4
Device Handling 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
Manufacturing, Packaging or Shipping Problem	2	2
Nonstandard Device	2	2
Device Markings/Labelling Problem	2	2
Crack	2	2
Device-Device Incompatibility	2	2
Material Twisted/Bent	1	1
Failure to Align	1	1
Lack of Effect	1	1
Difficult to Insert	1	1
Difficult or Delayed Positioning	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1206	1206
Inadequate Osseointegration	966	966
Implant Pain	570	570
Cyst(s)	553	553
Unspecified Infection	379	379
Pain	252	252
Failure of Implant	175	175
Swelling/ Edema	159	159
No Clinical Signs, Symptoms or Conditions	158	158
Loss of Range of Motion	143	143
Osteolysis	134	134
Bone Fracture(s)	126	126
Injury	87	87
Limb Fracture	84	84
Wound Dehiscence	82	82
Ambulation Difficulties	69	69
Post Operative Wound Infection	61	61
Patient Problem/Medical Problem	57	57
Bacterial Infection	56	56
Ossification	44	44
Discomfort	42	42
Subluxation	40	40
Impaired Healing	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	35
Joint Laxity	35	35
Deformity/ Disfigurement	26	26
Arthritis	22	22
Joint Dislocation	18	18
Numbness	18	18
Inflammation	17	17
Fluid Discharge	17	17
Nerve Damage	16	16
Erythema	15	15
Scar Tissue	14	14
No Code Available	14	14
Fall	12	12
Osteopenia/ Osteoporosis	11	11
Malunion of Bone	10	10
Fever	10	10
Necrosis	9	9
Rheumatoid Arthritis	9	9
Foreign Body Reaction	8	8
Unspecified Tissue Injury	8	8
Purulent Discharge	7	7
Foreign Body In Patient	7	7
No Information	7	7
Arthralgia	7	7
Non-union Bone Fracture	6	6
Capsular Contracture	6	6
Ankylosis	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