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

Premarket Reviews
Manufacturer	Decision
ACUMED LLC
	SUBSTANTIALLY EQUIVALENT	1
BIOPOLY, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	1
IGNITE ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES USA, LLC
	SUBSTANTIALLY EQUIVALENT	2
SKELETAL DYNAMICS INC
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES USA, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	314	326
Unintended Movement	200	200
Insufficient Information	111	119
Loose or Intermittent Connection	98	107
Device Slipped	96	96
Device Dislodged or Dislocated	88	106
Detachment of Device or Device Component	68	68
Detachment Of Device Component	67	67
Migration or Expulsion of Device	55	55
Loosening of Implant Not Related to Bone-Ingrowth	53	53
Appropriate Term/Code Not Available	52	52
Material Separation	47	47
Unstable	45	47
Break	27	27
Device Operates Differently Than Expected	24	24
Migration	23	25
Osseointegration Problem	21	39
Inadequacy of Device Shape and/or Size	18	18
Fracture	15	15
Patient-Device Incompatibility	14	14
Mechanical Problem	13	13
Naturally Worn	12	12
Failure To Adhere Or Bond	10	10
Nonstandard Device	10	10
Component Missing	9	9
Noise, Audible	9	9
Fitting Problem	9	9
Disassembly	8	8
Inaccurate Information	7	7
Malposition of Device	6	6
Patient Device Interaction Problem	6	6
Loss of Osseointegration	6	6
Difficult to Advance	5	5
Packaging Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Material Integrity Problem	4	4
Component or Accessory Incompatibility	4	4
Failure to Osseointegrate	4	4
Material Deformation	4	4
Positioning Problem	3	3
Metal Shedding Debris	3	3
Failure to Align	3	3
Connection Problem	3	3
Device Packaging Compromised	3	3
Material Erosion	2	2
Separation Failure	2	2
Unsealed Device Packaging	2	2
Physical Resistance/Sticking	2	2
Expiration Date Error	2	2
Loss of or Failure to Bond	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	388	388
No Code Available	345	345
Failure of Implant	276	276
No Known Impact Or Consequence To Patient	165	165
Loss of Range of Motion	106	106
No Information	95	95
Osteolysis	68	68
Ossification	47	47
Insufficient Information	43	71
Bone Fracture(s)	40	42
Injury	36	36
Unspecified Infection	29	31
Inadequate Osseointegration	24	42
Arthritis	21	21
Joint Dislocation	20	29
Limited Mobility Of The Implanted Joint	20	20
Discomfort	18	18
No Clinical Signs, Symptoms or Conditions	17	17
Fall	14	14
Weakness	14	14
Tissue Damage	13	13
Joint Laxity	13	24
Swelling	13	13
Nerve Damage	12	12
Patient Problem/Medical Problem	11	11
Muscular Rigidity	11	11
Inflammation	11	11
Non-union Bone Fracture	11	11
Impaired Healing	10	10
Erosion	9	9
No Consequences Or Impact To Patient	8	8
Implant Pain	8	8
Metal Related Pathology	7	7
Swelling/ Edema	7	7
Bacterial Infection	6	6
Scar Tissue	6	6
Sedation	6	6
Reaction	5	5
Subluxation	5	5
Hypoesthesia	5	5
Unspecified Tissue Injury	5	5
Cyst(s)	5	5
Fatigue	5	5
Irritation	4	4
Hypersensitivity/Allergic reaction	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Ambulation Difficulties	4	4
Osteopenia/ Osteoporosis	4	4
Fracture, Arm	4	4
Joint Disorder	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Acumed LLC	II	May-31-2017
2	Biomet, Inc.	II	May-13-2014
3	Howmedica Osteonics Corp.	II	Aug-08-2018
4	Skeletal Dynamics	II	Dec-12-2014
5	Small Bone Innovations, Inc.	II	Oct-29-2013
6	Synthes (USA) Products LLC	II	May-12-2022
7	Synthes (USA) Products LLC	II	Feb-02-2017
8	Synthes USA HQ, Inc.	II	May-03-2013
9	Wright Medical Technology Inc	II	Sep-21-2020
10	Wright Medical Technology, Inc.	II	Oct-04-2022
11	Wright Medical Technology, Inc.	II	Feb-06-2020
12	Zimmer Biomet, Inc.	II	Dec-20-2017