TPLC - Total Product Life Cycle

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Device	appliance, fixation, nail/blade/plate combination, multiple component, metal composite
Product Code	LXT
Regulation Number	888.3030
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	57	57
Mechanical Problem	48	48
Adverse Event Without Identified Device or Use Problem	47	47
Packaging Problem	26	26
Manufacturing, Packaging or Shipping Problem	23	23
Fracture	17	17
Difficult to Insert	17	17
Insufficient Information	17	17
Migration	15	15
Malposition of Device	14	14
Device-Device Incompatibility	13	13
Appropriate Term/Code Not Available	13	13
Migration or Expulsion of Device	12	12
Crack	9	9
Device Operates Differently Than Expected	8	8
Device Contaminated During Manufacture or Shipping	8	8
Physical Property Issue	7	7
Device Slipped	7	7
Connection Problem	6	6
Component Missing	6	6
Fitting Problem	6	6
Device Contamination with Chemical or Other Material	6	6
Positioning Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Corroded	5	5
Device Packaging Compromised	5	5
Device Markings/Labelling Problem	5	5
Material Deformation	5	5
Detachment Of Device Component	4	4
Unsealed Device Packaging	4	4
Incorrect Device Or Component Shipped	4	4
Tear, Rip or Hole in Device Packaging	4	4
Material Integrity Problem	3	3
Mechanical Jam	3	3
Loose or Intermittent Connection	3	3
Material Fragmentation	3	3
Delivered as Unsterile Product	3	3
Separation Failure	2	2
Unintended Movement	2	2
Defective Component	2	2
Material Erosion	2	2
Difficult to Remove	2	2
Shipping Damage or Problem	2	2
Positioning Failure	2	2
Out-Of-Box Failure	2	2
Bent	2	2
Inadequacy of Device Shape and/or Size	2	2
Unstable	2	2
Image Orientation Incorrect	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	71	71
No Known Impact Or Consequence To Patient	61	61
No Code Available	61	61
Pain	43	43
No Clinical Signs, Symptoms or Conditions	38	38
No Information	30	30
Failure of Implant	25	25
No Consequences Or Impact To Patient	20	20
Non-union Bone Fracture	19	19
Unspecified Infection	15	15
Bone Fracture(s)	7	7
Device Embedded In Tissue or Plaque	5	5
Foreign Body In Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Impaired Healing	5	5
Insufficient Information	4	4
Tissue Damage	4	4
Inflammation	3	3
Post Operative Wound Infection	3	3
Irritation	3	3
Loss of Range of Motion	3	3
Injury	2	2
Complaint, Ill-Defined	2	2
Nerve Damage	2	2
Swelling	2	2
Fall	2	2
Unspecified Tissue Injury	2	2
Disability	1	1
Limited Mobility Of The Implanted Joint	1	1
Osteopenia/ Osteoporosis	1	1
Ossification	1	1
Neurological Deficit/Dysfunction	1	1
Skin Irritation	1	1
Muscular Rigidity	1	1
Discomfort	1	1
Osteolysis	1	1
Numbness	1	1
Wound Dehiscence	1	1
Sedation	1	1
Fluid Discharge	1	1
Skin Infection	1	1
Physical Asymmetry	1	1
Hemorrhage/Bleeding	1	1
Patient Problem/Medical Problem	1	1
Arthritis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Mar-08-2016
2	Biomet, Inc.	II	Apr-14-2015
3	CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.	II	Jun-28-2022
4	Zimmer Biomet, Inc.	II	Jan-10-2019
5	Zimmer Inc.	II	Jun-30-2009