TPLC - Total Product Life Cycle

show TPLC since

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	266	278
Device Slipped	79	79
Detachment of Device or Device Component	62	62
Loosening of Implant Not Related to Bone-Ingrowth	54	54
Device Dislodged or Dislocated	53	71
Unintended Movement	52	52
Loose or Intermittent Connection	50	59
Insufficient Information	50	58
Appropriate Term/Code Not Available	43	43
Migration	23	25
Osseointegration Problem	21	39
Material Separation	21	21
Unstable	14	16
Inadequacy of Device Shape and/or Size	13	13
Mechanical Problem	12	12
Patient-Device Incompatibility	11	11
Fracture	11	11
Nonstandard Device	10	10
Noise, Audible	9	9
Inaccurate Information	7	7
Naturally Worn	7	7
Device Operates Differently Than Expected	7	7
Migration or Expulsion of Device	7	7
Break	7	7
Patient Device Interaction Problem	6	6
Loss of Osseointegration	6	6
Component Missing	5	5
Failure to Osseointegrate	4	4
Material Deformation	4	4
Detachment Of Device Component	3	3
Use of Device Problem	2	2
Failure To Adhere Or Bond	2	2
Packaging Problem	2	2
Misassembly by Users	2	2
Material Integrity Problem	2	2
Separation Failure	2	2
Physical Resistance/Sticking	2	2
Fitting Problem	2	2
Degraded	1	1
Difficult to Insert	1	1
Human Factors Issue	1	1
Positioning Failure	1	1
Material Too Rigid or Stiff	1	1
Moisture Damage	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Expiration Date Error	1	1
Crack	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	230	230
No Code Available	160	160
Failure of Implant	111	111
Loss of Range of Motion	81	81
No Known Impact Or Consequence To Patient	67	67
Osteolysis	57	57
No Information	56	56
Ossification	46	46
Insufficient Information	43	71
Bone Fracture(s)	35	37
Injury	32	32
Inadequate Osseointegration	26	44
Unspecified Infection	23	25
Arthritis	17	17
Joint Laxity	17	28
No Clinical Signs, Symptoms or Conditions	17	17
Joint Dislocation	14	23
Subluxation	13	13
Discomfort	12	12
Implant Pain	12	12
Weakness	11	11
Nerve Damage	10	10
Muscular Rigidity	10	10
Swelling	8	8
Patient Problem/Medical Problem	8	8
Metal Related Pathology	7	7
Tissue Damage	7	7
Limited Mobility Of The Implanted Joint	7	7
Swelling/ Edema	7	7
Scar Tissue	6	6
Fatigue	5	5
Inflammation	5	5
Erosion	5	5
Bacterial Infection	5	5
Hypoesthesia	5	5
Unspecified Tissue Injury	5	5
Ambulation Difficulties	4	4
Osteopenia/ Osteoporosis	4	4
Impaired Healing	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Nausea	3	3
Unspecified Musculoskeletal problem	3	3
Cyst(s)	3	3
Muscle/Tendon Damage	3	3
Death	3	3
Fracture, Arm	2	2
Joint Contracture	2	2
Therapeutic Response, Decreased	2	2
Neuropathy	2	2
Calcium Deposits/Calcification	2	2

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