TPLC - Total Product Life Cycle

• Device: prosthesis, elbow, hemi-, radial, polymer
• Product Code: KWI
• Regulation Number: 888.3170
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	1
IGNITE ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES USA, LLC
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2018	202	202
2019	214	214
2020	118	118
2021	44	44
2022	44	76
2023	39	39

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	191	203
Device Slipped	75	75
Unintended Movement	52	52
Loose or Intermittent Connection	50	59
Detachment of Device or Device Component	46	46
Loosening of Implant Not Related to Bone-Ingrowth	44	44
Appropriate Term/Code Not Available	43	43
Insufficient Information	38	38
Device Dislodged or Dislocated	37	46
Migration	22	24
Material Separation	21	21
Mechanical Problem	12	12
Inadequacy of Device Shape and/or Size	11	11
Nonstandard Device	10	10
Fracture	9	9
Patient-Device Incompatibility	8	8
Device Operates Differently Than Expected	7	7
Break	7	7
Noise, Audible	7	7
Naturally Worn	6	6
Migration or Expulsion of Device	5	5
Unstable	4	4
Loss of Osseointegration	4	4
Failure to Osseointegrate	4	4
Inaccurate Information	4	4
Detachment Of Device Component	3	3
Use of Device Problem	2	2
Failure To Adhere Or Bond	2	2
Component Missing	2	2
Material Deformation	2	2
Material Integrity Problem	2	2
Misassembly by Users	2	2
Patient Device Interaction Problem	2	2
Physical Resistance/Sticking	2	2
Packaging Problem	1	1
Positioning Problem	1	1
Device Operational Issue	1	1
Human Factors Issue	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Defective Device	1	1
Connection Problem	1	1
Difficult to Insert	1	1
Material Too Rigid or Stiff	1	1
Crack	1	1
Positioning Failure	1	1
Moisture Damage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	206	206
No Code Available	160	160
Failure of Implant	89	89
Loss of Range of Motion	70	70
No Known Impact Or Consequence To Patient	67	67
No Information	56	56
Osteolysis	41	41
Ossification	33	33
Injury	32	32
Bone Fracture(s)	27	29
Insufficient Information	26	54
No Clinical Signs, Symptoms or Conditions	11	11
Weakness	11	11
Unspecified Infection	10	12
Muscular Rigidity	10	10
Nerve Damage	10	10
Arthritis	10	10
Joint Dislocation	10	10
Discomfort	9	9
Patient Problem/Medical Problem	8	8
Swelling	8	8
Tissue Damage	7	7
Limited Mobility Of The Implanted Joint	7	7
Implant Pain	7	7
Hypoesthesia	5	5
Inflammation	5	5
Bacterial Infection	5	5
Fatigue	5	5
Scar Tissue	4	4
Impaired Healing	4	4
Ambulation Difficulties	4	4
Unspecified Tissue Injury	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Joint Laxity	3	3
Inadequate Osseointegration	3	3
Cyst(s)	3	3
Death	3	3
Erythema	2	2
Anemia	2	2
Hypersensitivity/Allergic reaction	2	2
Erosion	2	2
Calcium Deposits/Calcification	2	2
Failure to Anastomose	2	2
Wound Dehiscence	2	2
Neurological Deficit/Dysfunction	2	2
Neuropathy	2	2
Synovitis	2	2
Therapeutic Response, Decreased	2	2
Osteopenia/ Osteoporosis	2	2
Reaction	2	2
Joint Disorder	2	2
Fracture, Arm	2	2
Muscle/Tendon Damage	2	2
Swelling/ Edema	2	2
Bone Shedding Debris	2	2
Unspecified Musculoskeletal problem	1	1
Joint Contracture	1	1
Ischemia Stroke	1	1
Unspecified Heart Problem	1	1
Renal Impairment	1	1
Subluxation	1	1
Complaint, Ill-Defined	1	1
Foreign Body In Patient	1	1
Not Applicable	1	1
No Consequences Or Impact To Patient	1	1
Myalgia	1	1
Sepsis	1	1
Adhesion(s)	1	1
Hemorrhage/Bleeding	1	1
Foreign Body Reaction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Aug-08-2018
2	Synthes (USA) Products LLC	II	May-12-2022
3	Wright Medical Technology Inc	II	Sep-21-2020
4	Wright Medical Technology, Inc.	II	Oct-04-2022
5	Wright Medical Technology, Inc.	II	Feb-06-2020