TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	205	217
Unintended Movement	148	148
Insufficient Information	92	92
Device Slipped	79	79
Loose or Intermittent Connection	75	84
Device Dislodged or Dislocated	58	67
Detachment of Device or Device Component	51	51
Appropriate Term/Code Not Available	50	50
Detachment Of Device Component	40	40
Loosening of Implant Not Related to Bone-Ingrowth	40	40
Migration or Expulsion of Device	34	34
Material Separation	33	33
Migration	21	23
Device Operates Differently Than Expected	15	15
Break	14	14
Mechanical Problem	13	13
Inadequacy of Device Shape and/or Size	12	12
Unstable	12	12
Nonstandard Device	10	10
Fracture	9	9
Patient-Device Incompatibility	8	8
Failure To Adhere Or Bond	8	8
Disassembly	8	8
Naturally Worn	7	7
Component Missing	6	6
Noise, Audible	6	6
Loss of Osseointegration	5	5
Inaccurate Information	4	4
Failure to Osseointegrate	4	4
Fitting Problem	3	3
Material Deformation	2	2
Material Integrity Problem	2	2
Physical Resistance/Sticking	2	2
Misassembly by Users	2	2
Packaging Problem	2	2
Use of Device Problem	2	2
Positioning Problem	2	2
Difficult to Insert	1	1
Moisture Damage	1	1
Malposition of Device	1	1
Connection Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Loss of or Failure to Bond	1	1
Crack	1	1
Defective Device	1	1
Delamination	1	1
Patient Device Interaction Problem	1	1
Device Operational Issue	1	1
Human Factors Issue	1	1
Positioning Failure	1	1
Difficult to Remove	1	1
Material Too Rigid or Stiff	1	1
Improper or Incorrect Procedure or Method	1	1
Misconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	307	307
No Code Available	274	274
Failure of Implant	177	177
No Known Impact Or Consequence To Patient	111	111
Loss of Range of Motion	84	84
No Information	80	80
Osteolysis	45	45
Injury	36	36
Ossification	35	35
Insufficient Information	26	54
Bone Fracture(s)	24	26
Unspecified Infection	18	20
Limited Mobility Of The Implanted Joint	15	15
Joint Dislocation	14	14
Discomfort	13	13
Weakness	12	12
Nerve Damage	11	11
No Clinical Signs, Symptoms or Conditions	11	11
Tissue Damage	10	10
Arthritis	10	10
Muscular Rigidity	9	9
Patient Problem/Medical Problem	8	8
Swelling	8	8
Hypoesthesia	5	5
Fall	5	5
Bacterial Infection	5	5
Non-union Bone Fracture	5	5
Impaired Healing	5	5
Scar Tissue	4	4
Ambulation Difficulties	4	4
Fatigue	4	4
Inflammation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Cyst(s)	3	3
Joint Disorder	3	3
Death	3	3
Unspecified Tissue Injury	3	3
Implant Pain	3	3
Fracture, Arm	3	3
No Consequences Or Impact To Patient	3	3
Muscle Weakness	2	2
Neuropathy	2	2
Wound Dehiscence	2	2
Calcium Deposits/Calcification	2	2
Erythema	2	2
Osteopenia/ Osteoporosis	2	2
Numbness	2	2
Muscle/Tendon Damage	2	2
Bone Shedding Debris	2	2
Synovitis	2	2
Reaction	2	2
Inadequate Osseointegration	2	2
Seroma	2	2
Foreign Body In Patient	2	2
Therapeutic Response, Decreased	2	2
Joint Laxity	2	2
Hypersensitivity/Allergic reaction	2	2
Failure to Anastomose	2	2
Neurological Deficit/Dysfunction	2	2
Neck Stiffness	1	1
Sedation	1	1
Not Applicable	1	1
Foreign Body Reaction	1	1
Myalgia	1	1
Swelling/ Edema	1	1
No Patient Involvement	1	1
Complaint, Ill-Defined	1	1
Adhesion(s)	1	1
Rupture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Acumed LLC	II	May-31-2017
2	Howmedica Osteonics Corp.	II	Aug-08-2018
3	Synthes (USA) Products LLC	II	May-12-2022
4	Synthes (USA) Products LLC	II	Feb-02-2017
5	Wright Medical Technology Inc	II	Sep-21-2020
6	Wright Medical Technology, Inc.	II	Oct-04-2022
7	Wright Medical Technology, Inc.	II	Feb-06-2020
8	Zimmer Biomet, Inc.	II	Dec-20-2017