TPLC - Total Product Life Cycle

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Device	prosthesis, elbow, hemi-, radial, polymer
Regulation Description	Elbow joint radial (hemi-elbow) polymer prosthesis.
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	224	236
Loosening of Implant Not Related to Bone-Ingrowth	53	53
Detachment of Device or Device Component	50	50
Device Slipped	35	35
Device Dislodged or Dislocated	32	50
Osseointegration Problem	23	41
Insufficient Information	19	27
Corroded	17	17
Loose or Intermittent Connection	16	25
Appropriate Term/Code Not Available	13	13
Unstable	12	14
Migration	12	14
Inadequacy of Device Shape and/or Size	10	10
Fracture	9	9
Material Separation	8	8
Inaccurate Information	7	7
Patient Device Interaction Problem	6	6
Naturally Worn	6	6
Unintended Movement	5	5
Loss of Osseointegration	5	5
Material Deformation	4	4
Patient-Device Incompatibility	4	4
Break	4	4
Noise, Audible	4	4
Component Missing	3	3
Migration or Expulsion of Device	3	3
Positioning Failure	2	2
Packaging Problem	2	2
Misassembly by Users	2	2
Separation Failure	2	2
Malposition of Device	2	2
Moisture Damage	1	1
Degraded	1	1
Use of Device Problem	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Expiration Date Error	1	1
Physical Resistance/Sticking	1	1
Connection Problem	1	1
Fitting Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	111	111
Loss of Range of Motion	74	74
Insufficient Information	68	96
Failure of Implant	68	68
Ossification	38	38
No Code Available	33	33
Inadequate Osseointegration	26	44
Bone Fracture(s)	26	28
Metal Related Pathology	25	25
Osteolysis	24	24
Joint Laxity	20	31
Unspecified Infection	19	21
No Clinical Signs, Symptoms or Conditions	17	17
No Information	13	13
Subluxation	13	13
Implant Pain	12	12
Arthritis	11	11
Joint Dislocation	10	19
Muscular Rigidity	10	10
No Known Impact Or Consequence To Patient	9	9
Discomfort	8	8
Scar Tissue	8	8
Swelling/ Edema	7	7
Tissue Damage	7	7
Unspecified Tissue Injury	6	6
Weakness	5	5
Fatigue	5	5
Bacterial Infection	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Erosion	5	5
Inflammation	4	4
Osteopenia/ Osteoporosis	4	4
Limited Mobility Of The Implanted Joint	4	4
Joint Contracture	4	4
Nerve Damage	4	4
Muscle/Tendon Damage	3	3
Unspecified Musculoskeletal problem	3	3
Nausea	3	3
Therapeutic Response, Decreased	2	2
Limb Fracture	2	2
Failure to Anastomose	2	2
Peripheral Nervous Injury	2	2
Hypoesthesia	2	2
Swelling	2	2
Bone Shedding Debris	2	2
Injury	2	2
Neurological Deficit/Dysfunction	2	2
Anemia	2	2
Synovitis	2	2
Hypersensitivity/Allergic reaction	2	2

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