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
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	4
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	1823	1823
Osseointegration Problem	819	819
Insufficient Information	728	728
Migration	495	495
Loss of Osseointegration	135	135
Fracture	80	80
Break	79	79
Loosening of Implant Not Related to Bone-Ingrowth	72	72
Naturally Worn	46	46
Malposition of Device	41	41
Device Dislodged or Dislocated	41	41
Appropriate Term/Code Not Available	39	39
Unstable	29	29
Loss of or Failure to Bond	27	27
Use of Device Problem	26	26
Inadequacy of Device Shape and/or Size	25	25
Unintended Movement	25	25
Failure to Osseointegrate	16	16
Detachment of Device or Device Component	16	16
Positioning Failure	15	15
Device Difficult to Setup or Prepare	13	13
Patient Device Interaction Problem	12	12
Biocompatibility	10	10
Patient-Device Incompatibility	10	10
Off-Label Use	9	9
Improper or Incorrect Procedure or Method	9	9
Defective Device	8	8
Mechanical Jam	7	7
Component Missing	7	7
Positioning Problem	6	6
Inaccurate Information	6	6
Degraded	5	5
Material Deformation	5	5
No Apparent Adverse Event	4	4
Material Fragmentation	4	4
Device Handling Problem	4	4
Material Discolored	3	3
Material Erosion	3	3
Collapse	3	3
Material Separation	3	3
Loose or Intermittent Connection	3	3
Nonstandard Device	2	2
Difficult or Delayed Positioning	2	2
Device Damaged by Another Device	2	2
Shipping Damage or Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Device Markings/Labelling Problem	2	2
Peeled/Delaminated	2	2
Crack	2	2
Mechanical Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1176	1176
Inadequate Osseointegration	947	947
Implant Pain	570	570
Cyst(s)	548	548
Unspecified Infection	447	447
Pain	260	260
Failure of Implant	179	179
Injury	170	170
No Clinical Signs, Symptoms or Conditions	158	158
Swelling/ Edema	156	156
Loss of Range of Motion	141	141
Osteolysis	140	140
Bone Fracture(s)	137	137
No Code Available	121	121
Limb Fracture	83	83
Wound Dehiscence	82	82
Patient Problem/Medical Problem	67	67
Ambulation Difficulties	66	66
Post Operative Wound Infection	55	55
Bacterial Infection	50	50
No Known Impact Or Consequence To Patient	43	43
Discomfort	42	42
Impaired Healing	42	42
Subluxation	40	40
Ossification	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	35
Joint Laxity	35	35
Joint Dislocation	26	26
Deformity/ Disfigurement	26	26
Numbness	23	23
Arthritis	22	22
Nerve Damage	17	17
Fluid Discharge	17	17
Inflammation	17	17
Scar Tissue	16	16
Erythema	15	15
No Information	15	15
Fall	12	12
Osteopenia/ Osteoporosis	11	11
Fever	10	10
Malunion of Bone	10	10
Rheumatoid Arthritis	9	9
Foreign Body In Patient	8	8
Foreign Body Reaction	8	8
Unspecified Tissue Injury	8	8
Necrosis	8	8
Tissue Damage	8	8
Purulent Discharge	7	7
Arthralgia	7	7
Capsular Contracture	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	Integra LifeSciences Corp.	II	Apr-16-2019
5	Wright Medical Technology Inc	II	Dec-01-2021
6	Wright Medical Technology Inc	II	May-07-2020
7	Wright Medical Technology, Inc.	II	Apr-04-2024
8	Wright Medical Technology, Inc.	II	Jul-07-2023
9	Wright Medical Technology, Inc.	II	Oct-27-2022
10	Wright Medical Technology, Inc.	II	Jun-27-2022
11	Wright Medical Technology, Inc.	II	Nov-25-2019
12	Zimmer Biomet, Inc.	II	Nov-07-2019