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	170	182
Device Slipped	70	70
Detachment of Device or Device Component	47	47
Loose or Intermittent Connection	41	50
Loosening of Implant Not Related to Bone-Ingrowth	40	40
Appropriate Term/Code Not Available	33	33
Unintended Movement	32	32
Device Dislodged or Dislocated	24	42
Insufficient Information	14	14
Inadequacy of Device Shape and/or Size	13	13
Migration	12	14
Material Separation	10	10
Fracture	7	7
Mechanical Problem	7	7
Inaccurate Information	7	7
Patient Device Interaction Problem	6	6
Naturally Worn	6	6
Noise, Audible	4	4
Material Deformation	4	4
Component Missing	4	4
Loss of Osseointegration	4	4
Patient-Device Incompatibility	4	4
Unstable	3	3
Migration or Expulsion of Device	3	3
Break	3	3
Fitting Problem	2	2
Misassembly by Users	2	2
Osseointegration Problem	2	11
Packaging Problem	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Physical Resistance/Sticking	1	1
Use of Device Problem	1	1
Connection Problem	1	1
Degraded	1	1
Positioning Failure	1	1
Moisture Damage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	162	162
No Code Available	110	110
Failure of Implant	87	87
Loss of Range of Motion	63	63
No Known Impact Or Consequence To Patient	40	40
Ossification	34	34
Insufficient Information	33	61
Injury	29	29
Osteolysis	26	26
No Information	26	26
Bone Fracture(s)	26	28
No Clinical Signs, Symptoms or Conditions	14	14
Joint Dislocation	11	20
Weakness	11	11
Muscular Rigidity	10	10
Discomfort	9	9
Unspecified Infection	9	11
Arthritis	8	8
Implant Pain	8	8
Metal Related Pathology	7	7
Tissue Damage	7	7
Scar Tissue	6	6
Nerve Damage	5	5
Bacterial Infection	5	5
Inflammation	5	5
Fatigue	5	5
Joint Laxity	5	14
Unspecified Tissue Injury	5	5
Swelling/ Edema	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hypoesthesia	4	4
Osteopenia/ Osteoporosis	4	4
Limited Mobility Of The Implanted Joint	4	4
Swelling	4	4
Cyst(s)	3	3
Inadequate Osseointegration	3	12
Unspecified Musculoskeletal problem	3	3
Bone Shedding Debris	2	2
Muscle/Tendon Damage	2	2
Impaired Healing	2	2
Joint Disorder	2	2
Erythema	2	2
Erosion	2	2
Calcium Deposits/Calcification	2	2
Failure to Anastomose	2	2
Anemia	2	2
Synovitis	2	2
Hypersensitivity/Allergic reaction	2	2
Therapeutic Response, Decreased	2	2
Neurological Deficit/Dysfunction	2	2
Neuropathy	1	1
Sepsis	1	1
No Consequences Or Impact To Patient	1	1
Myalgia	1	1
Adhesion(s)	1	1
Foreign Body Reaction	1	1
Hemorrhage/Bleeding	1	1
Fracture, Arm	1	1
Reaction	1	1
Foreign Body In Patient	1	1
Patient Problem/Medical Problem	1	1
Ischemia Stroke	1	1
Unspecified Heart Problem	1	1
Renal Impairment	1	1
Subluxation	1	1
Ankylosis	1	1
Joint Contracture	1	1
Device Embedded In Tissue or Plaque	1	1

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