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	192	204
Detachment of Device or Device Component	42	42
Loosening of Implant Not Related to Bone-Ingrowth	38	38
Device Dislodged or Dislocated	26	45
Osseointegration Problem	24	42
Device Slipped	18	18
Corroded	17	17
Migration	14	16
Insufficient Information	12	20
Unstable	11	13
Fracture	10	10
Inaccurate Information	7	7
Inadequacy of Device Shape and/or Size	7	7
Break	6	6
Loose or Intermittent Connection	6	15
Patient Device Interaction Problem	6	6
Noise, Audible	3	3
Naturally Worn	3	3
Appropriate Term/Code Not Available	3	3
Component Missing	3	3
Patient-Device Incompatibility	3	3
Migration or Expulsion of Device	3	3
Material Deformation	2	2
Packaging Problem	2	2
Misassembly by Users	2	2
Separation Failure	2	2
Malposition of Device	2	2
Improper or Incorrect Procedure or Method	2	2
Loss of Osseointegration	2	2
Positioning Failure	1	1
Degraded	1	1
Material Separation	1	1
Moisture Damage	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Expiration Date Error	1	1
Connection Problem	1	1
Crack	1	1
Physical Resistance/Sticking	1	1
Device-Device Incompatibility	1	1
Fitting Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	72	72
Insufficient Information	67	95
Loss of Range of Motion	61	61
Failure of Implant	60	61
Ossification	36	36
Metal Related Pathology	27	27
Inadequate Osseointegration	26	44
Joint Laxity	20	31
No Clinical Signs, Symptoms or Conditions	19	19
Unspecified Infection	18	20
Bone Fracture(s)	18	20
Osteolysis	17	17
Subluxation	13	13
Implant Pain	13	13
Discomfort	8	8
Arthritis	7	7
Joint Dislocation	7	16
Swelling/ Edema	7	7
Unspecified Tissue Injury	6	6
Muscular Rigidity	6	6
Erosion	5	5
Joint Contracture	5	5
Scar Tissue	5	5
Weakness	3	3
Osteopenia/ Osteoporosis	3	3
Limb Fracture	3	3
Unspecified Musculoskeletal problem	3	3
Nausea	3	3
Fatigue	3	3
Bacterial Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Bone Shedding Debris	2	2
Anemia	2	2
Peripheral Nervous Injury	2	2
Foreign Body In Patient	1	1
Myalgia	1	1
Fall	1	1
Perforation	1	1
Inflammation	1	1
Renal Impairment	1	1
Ankylosis	1	1
Muscle/Tendon Damage	1	1
Sepsis	1	1
Unspecified Heart Problem	1	1
Arthralgia	1	1
Hemorrhage/Bleeding	1	1
Infiltration into Tissue	1	1
Neuropathy	1	1
Ischemia Stroke	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	Oct-04-2022