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
Insufficient Information	17	17
Difficult to Insert	17	17
Migration	15	15
Malposition of Device	14	14
Appropriate Term/Code Not Available	13	13
Device-Device Incompatibility	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
Component Missing	6	6
Fitting Problem	6	6
Connection Problem	6	6
Device Contamination with Chemical or Other Material	6	6
Material Deformation	5	5
Corroded	5	5
Improper or Incorrect Procedure or Method	5	5
Positioning Problem	5	5
Device Packaging Compromised	5	5
Device Markings/Labelling Problem	5	5
Detachment Of Device Component	4	4
Tear, Rip or Hole in Device Packaging	4	4
Incorrect Device Or Component Shipped	4	4
Unsealed Device Packaging	4	4
Delivered as Unsterile Product	3	3
Loose or Intermittent Connection	3	3
Mechanical Jam	3	3
Material Integrity Problem	3	3
Material Fragmentation	3	3
Bent	2	2
Positioning Failure	2	2
Difficult to Remove	2	2
Separation Failure	2	2
Unintended Movement	2	2
Material Erosion	2	2
Defective Component	2	2
Unstable	2	2
Out-Of-Box Failure	2	2
Shipping Damage or Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Abrasion From Instrument Or Another Object	1	1
Peeled/Delaminated	1	1

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