TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AUXEIN MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BIOMET INC.
	SUBSTANTIALLY EQUIVALENT	1
NARANG MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW INC.
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1718	1718
Break	717	717
Device-Device Incompatibility	495	495
Insufficient Information	216	216
Fracture	205	205
Migration	118	118
Migration or Expulsion of Device	93	93
Material Deformation	76	76
Manufacturing, Packaging or Shipping Problem	65	65
Material Twisted/Bent	48	48
Detachment of Device or Device Component	42	42
Appropriate Term/Code Not Available	40	40
Failure to Align	36	36
Device Operates Differently Than Expected	34	34
Unintended Movement	33	33
Loose or Intermittent Connection	29	29
No Apparent Adverse Event	29	29
Device Slipped	25	25
Loosening of Implant Not Related to Bone-Ingrowth	21	21
Entrapment of Device	21	21
Connection Problem	19	19
Use of Device Problem	19	19
Mechanical Jam	17	17
Improper or Incorrect Procedure or Method	17	17
Crack	16	16
Fitting Problem	13	13
Device Dislodged or Dislocated	13	13
Difficult to Advance	13	13
Material Integrity Problem	13	13
Difficult to Remove	12	12
Bent	12	12
Malposition of Device	10	10
Material Fragmentation	10	10
Defective Device	9	9
Patient-Device Incompatibility	9	9
Device Difficult to Maintain	8	8
Device Markings/Labelling Problem	8	8
Delivered as Unsterile Product	7	7
Sticking	6	6
Component Missing	6	6
Difficult to Insert	6	6
Naturally Worn	6	6
Patient Device Interaction Problem	6	6
Mechanical Problem	5	5
Inadequacy of Device Shape and/or Size	5	5
Failure To Adhere Or Bond	4	4
Nonstandard Device	4	4
Positioning Problem	4	4
Scratched Material	3	3
Unstable	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	782	782
No Clinical Signs, Symptoms or Conditions	764	764
Non-union Bone Fracture	599	599
Unspecified Infection	396	396
Injury	396	396
Failure of Implant	388	388
Pain	351	351
No Consequences Or Impact To Patient	209	209
Bone Fracture(s)	190	190
No Known Impact Or Consequence To Patient	147	147
Impaired Healing	142	142
Insufficient Information	132	132
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	85	85
Discomfort	71	71
Physical Asymmetry	66	66
Necrosis	58	58
No Information	55	55
Post Operative Wound Infection	54	54
Deformity/ Disfigurement	49	49
Loss of Range of Motion	47	47
Foreign Body In Patient	45	45
Malunion of Bone	41	41
No Patient Involvement	33	33
Skin Inflammation/ Irritation	29	29
Inflammation	27	27
Thrombosis/Thrombus	25	25
Device Embedded In Tissue or Plaque	20	20
Fall	20	20
Perforation	20	20
Tissue Damage	19	19
Nerve Damage	19	19
Hip Fracture	17	17
Ambulation Difficulties	16	16
Unspecified Tissue Injury	15	15
Hypersensitivity/Allergic reaction	14	14
Not Applicable	14	14
Irritation	13	13
Patient Problem/Medical Problem	13	13
Hematoma	13	13
Implant Pain	12	12
Bacterial Infection	11	11
Sedation	10	10
Joint Dislocation	10	10
Swelling/ Edema	9	9
Cellulitis	9	9
Ossification	8	8
Reaction	8	8
Muscular Rigidity	8	8
Skin Irritation	8	8
Death	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew Orthopaedics GmbH	II	May-25-2022
2	Smith & Nephew, Inc.	II	Jan-06-2021
3	Smith & Nephew, Inc.	II	Jul-22-2020
4	Smith & Nephew, Inc.	II	Nov-16-2017
5	Zimmer Biomet, Inc.	II	Mar-27-2017