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	2
IN2BONES SAS
	SUBSTANTIALLY EQUIVALENT	3
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	5
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	4
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	2
WRIGHT MEDICAL TECHNOLOGY, INC. (STRYKER)
	SUBSTANTIALLY EQUIVALENT	2
WRIGHTMEDICALTECHNOLOGYINC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2122	2122
Osseointegration Problem	1079	1079
Insufficient Information	991	991
Migration	497	497
Loss of Osseointegration	168	168
Fracture	96	96
Loosening of Implant Not Related to Bone-Ingrowth	74	75
Break	70	70
Malposition of Device	53	53
Naturally Worn	52	52
Inadequacy of Device Shape and/or Size	46	46
Appropriate Term/Code Not Available	37	37
Device Dislodged or Dislocated	32	33
Unstable	31	31
Positioning Failure	22	22
Unintended Movement	21	21
Detachment of Device or Device Component	17	17
Failure to Osseointegrate	17	17
Use of Device Problem	16	16
Device Difficult to Setup or Prepare	14	14
Biocompatibility	10	10
Off-Label Use	10	10
Patient Device Interaction Problem	9	9
Defective Device	8	8
Patient-Device Incompatibility	7	7
Mechanical Jam	6	6
Inaccurate Information	6	6
Material Fragmentation	6	6
Material Deformation	6	6
Component Missing	6	6
Positioning Problem	5	5
Device Handling Problem	4	4
Structural Problem	4	4
Material Discolored	3	3
No Apparent Adverse Event	3	3
Device Appears to Trigger Rejection	3	3
Improper or Incorrect Procedure or Method	3	3
Device Damaged by Another Device	2	2
Shipping Damage or Problem	2	2
Lack of Effect	2	2
Difficult to Insert	2	2
Degraded	2	2
Material Separation	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Nonstandard Device	2	2
Device Markings/Labelling Problem	2	2
Crack	2	2
Loss of or Failure to Bond	2	2
Material Twisted/Bent	1	1
Failure to Align	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1533	1533
Inadequate Osseointegration	1247	1247
Cyst(s)	710	710
Implant Pain	592	593
Pain	474	474
Unspecified Infection	415	415
Swelling/ Edema	189	189
Loss of Range of Motion	181	181
Osteolysis	171	171
No Clinical Signs, Symptoms or Conditions	160	160
Failure of Implant	157	158
Bone Fracture(s)	139	139
Ossification	129	129
Post Operative Wound Infection	107	107
Limb Fracture	103	103
Wound Dehiscence	89	89
Ambulation Difficulties	85	85
Bacterial Infection	57	57
Subluxation	55	55
Joint Laxity	54	54
Impaired Healing	51	51
Discomfort	46	46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	38	38
Deformity/ Disfigurement	36	36
Numbness	31	31
Arthritis	28	28
Cellulitis	26	26
Fall	26	26
Inflammation	21	21
Joint Dislocation	21	21
Fluid Discharge	18	18
Nerve Damage	17	17
Scar Tissue	15	15
Malunion of Bone	14	14
Joint Contracture	11	11
Osteopenia/ Osteoporosis	11	11
Fever	10	10
Erythema	10	10
Unspecified Tissue Injury	10	10
Muscle/Tendon Damage	10	10
Rheumatoid Arthritis	9	9
Necrosis	9	9
Ankylosis	9	9
Foreign Body In Patient	8	8
Foreign Body Reaction	8	8
Damage to Ligament(s)	8	8
Neuropathy	8	8
Osteomyelitis	8	8
Metal Related Pathology	8	8
Purulent Discharge	7	7

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