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	212	224
Device Slipped	70	70
Detachment of Device or Device Component	50	50
Loosening of Implant Not Related to Bone-Ingrowth	46	46
Loose or Intermittent Connection	41	50
Appropriate Term/Code Not Available	33	33
Unintended Movement	32	32
Device Dislodged or Dislocated	30	48
Insufficient Information	24	32
Osseointegration Problem	21	39
Inadequacy of Device Shape and/or Size	13	13
Migration	12	14
Material Separation	10	10
Unstable	9	11
Mechanical Problem	7	7
Fracture	7	7
Inaccurate Information	7	7
Patient Device Interaction Problem	6	6
Naturally Worn	6	6
Patient-Device Incompatibility	4	4
Component Missing	4	4
Material Deformation	4	4
Loss of Osseointegration	4	4
Noise, Audible	4	4
Break	3	3
Migration or Expulsion of Device	3	3
Fitting Problem	2	2
Separation Failure	2	2
Packaging Problem	2	2
Misassembly by Users	2	2
Physical Resistance/Sticking	1	1
Expiration Date Error	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Moisture Damage	1	1
Degraded	1	1
Positioning Failure	1	1
Use of Device Problem	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	171	171
No Code Available	110	110
Failure of Implant	92	92
Loss of Range of Motion	65	65
Insufficient Information	43	71
Ossification	42	42
Osteolysis	41	41
No Known Impact Or Consequence To Patient	40	40
Injury	29	29
Bone Fracture(s)	28	30
No Information	26	26
Inadequate Osseointegration	23	41
No Clinical Signs, Symptoms or Conditions	17	17
Arthritis	14	14
Joint Laxity	13	24
Joint Dislocation	12	21
Weakness	11	11
Unspecified Infection	11	13
Muscular Rigidity	10	10
Discomfort	9	9
Implant Pain	8	8
Tissue Damage	7	7
Metal Related Pathology	7	7
Swelling/ Edema	7	7
Scar Tissue	6	6
Fatigue	5	5
Inflammation	5	5
Unspecified Tissue Injury	5	5
Subluxation	5	5
Bacterial Infection	5	5
Erosion	5	5
Nerve Damage	5	5
Limited Mobility Of The Implanted Joint	4	4
Osteopenia/ Osteoporosis	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hypoesthesia	4	4
Swelling	4	4
Nausea	3	3
Unspecified Musculoskeletal problem	3	3
Cyst(s)	3	3
Muscle/Tendon Damage	3	3
Therapeutic Response, Decreased	2	2
Calcium Deposits/Calcification	2	2
Joint Contracture	2	2
Failure to Anastomose	2	2
Erythema	2	2
Bone Shedding Debris	2	2
Neurological Deficit/Dysfunction	2	2
Anemia	2	2
Synovitis	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