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	2383	2383
Insufficient Device Problem Information	1211	1211
Osseointegration Problem	1180	1180
Migration	514	514
Loss of Osseointegration	234	234
Implant subsidence	145	145
Fracture	124	124
Loosening of Implant Not Related to Bone-Ingrowth	84	85
Break	71	71
Naturally Worn	63	63
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	36	36
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
Positioning Problem	7	7
Patient-Device Incompatibility	7	7
Inaccurate Information	6	6
Mechanical Jam	6	6
Material Fragmentation	6	6
Component Missing	6	6
Material Deformation	6	6
Peeled/Delaminated	4	4
Structural Problem	4	4
Device Handling Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Device Appears to Trigger Rejection	3	3
Collapse	3	3
Material Discolored	3	3
No Apparent Adverse Event	3	3
Nonstandard Device	2	2
Loss of or Failure to Bond	2	2
Device Damaged Prior to Receipt by User	2	2
Material Separation	2	2
Lack of Effect	2	2
Device Damaged by Another Device	2	2
Difficult to Insert	2	2
Degraded	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Defective Component	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1773	1773
Inadequate Osseointegration	1400	1400
Cyst(s)	780	780
Pain	650	650
Implant Pain	592	593
Unspecified Infection	445	445
Joint Impingement	225	225
Swelling/ Edema	215	215
Osteolysis	206	206
Loss of Range of Motion	188	188
No Clinical Signs, Symptoms or Conditions	169	169
Failure of Implant	157	158
Bone Fracture(s)	151	151
Extraskeletal ossification	143	143
Post Operative Wound Infection	135	135
Wound Dehiscence	109	109
Limb Fracture	108	108
Ambulation or Postural Difficulties	94	94
Joint Laxity	61	61
Subluxation	61	61
Bacterial Infection	60	60
Discomfort	53	53
Impaired Healing	51	51
Medical device site infection	48	48
Deformity/ Disfigurement	43	43
Arthritis	39	39
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	38	38
Numbness	37	37
Radiolucent Lines	35	35
Aseptic loosening	34	34
Erythema	31	31
Cellulitis	30	30
Fall	27	27
Necrosis	26	26
Inflammation	26	26
Joint Dislocation	26	26
Fluid Discharge	25	25
Periprosthetic fracture	20	20
Malunion of Bone	19	19
Scar Tissue	18	18
Nerve Damage	17	17
Osteopenia/ Osteoporosis	14	14
Capsular Contracture	12	12
Muscle/Tendon Damage	12	12
Metal Related Pathology	12	12
Joint Contracture	11	11
Ankylosis	10	10
Unspecified Tissue Injury	10	10
Wound Odor	10	10
Fever	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