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	3
WRIGHTMEDICALTECHNOLOGYINC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2347	2347
Insufficient Device Problem Information	1180	1180
Osseointegration Problem	1166	1166
Migration	514	514
Loss of Osseointegration	225	225
Implant subsidence	145	145
Fracture	122	122
Loosening of Implant Not Related to Bone-Ingrowth	82	83
Break	71	71
Naturally Worn	62	62
Malposition of Device	57	57
Inadequacy of Device Shape and/or Size	49	49
Device Dislodged or Dislocated	42	43
Appropriate Device Problem Term/Code Not Available	36	36
Unstable	33	33
Positioning Failure	24	24
Unintended Movement	22	22
Failure to Osseointegrate	21	21
Detachment of Device or Device Component	18	18
Use of Device Problem	16	16
Device Difficult to Setup or Prepare	15	15
Biocompatibility	11	11
Off-Label Use	10	10
Patient Device Interaction Problem	9	9
Defective Device	8	8
Patient-Device Incompatibility	7	7
Positioning Problem	7	7
Component Missing	6	6
Material Deformation	6	6
Mechanical Jam	6	6
Inaccurate Information	6	6
Material Fragmentation	6	6
Structural Problem	4	4
Device Handling Problem	4	4
Device Appears to Trigger Rejection	3	3
Collapse	3	3
No Apparent Adverse Event	3	3
Peeled/Delaminated	3	3
Material Discolored	3	3
Improper or Incorrect Procedure or Method	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Lack of Effect	2	2
Material Separation	2	2
Defective Component	2	2
Nonstandard Device	2	2
Degraded	2	2
Device Damaged by Another Device	2	2
Device Damaged Prior to Receipt by User	2	2
Difficult to Insert	2	2
Loss of or Failure to Bond	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1738	1738
Inadequate Osseointegration	1379	1379
Cyst(s)	761	761
Pain	627	627
Implant Pain	592	593
Unspecified Infection	436	436
Joint Impingement	220	220
Swelling/ Edema	214	214
Osteolysis	197	197
Loss of Range of Motion	188	188
No Clinical Signs, Symptoms or Conditions	169	169
Failure of Implant	157	158
Bone Fracture(s)	149	149
Extraskeletal ossification	143	143
Post Operative Wound Infection	135	135
Limb Fracture	108	108
Wound Dehiscence	103	103
Ambulation or Postural Difficulties	94	94
Subluxation	61	61
Bacterial Infection	60	60
Joint Laxity	58	58
Impaired Healing	51	51
Discomfort	50	50
Medical device site infection	46	46
Deformity/ Disfigurement	43	43
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	38	38
Numbness	37	37
Arthritis	35	35
Radiolucent Lines	35	35
Aseptic loosening	31	31
Erythema	31	31
Cellulitis	30	30
Fall	27	27
Joint Dislocation	26	26
Inflammation	26	26
Fluid Discharge	25	25
Periprosthetic fracture	20	20
Malunion of Bone	19	19
Necrosis	19	19
Scar Tissue	18	18
Nerve Damage	17	17
Osteopenia/ Osteoporosis	14	14
Muscle/Tendon Damage	12	12
Capsular Contracture	12	12
Joint Contracture	11	11
Metal Related Pathology	11	11
Ankylosis	10	10
Purulent Discharge	10	10
Unspecified Tissue Injury	10	10
Wound Odor	10	10

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