TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AAP IMPLANTATE AG
	SUBSTANTIALLY EQUIVALENT	1
ACUMED LLC
	SUBSTANTIALLY EQUIVALENT	1
BIOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
CITIEFFE S.R.L
	SUBSTANTIALLY EQUIVALENT	1
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EISERTECH, LLC
	SUBSTANTIALLY EQUIVALENT	1
GENOSSIS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MERETE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	4
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	1
SUMMIT MEDVENTURES
	SUBSTANTIALLY EQUIVALENT	1
SYNTEC SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TINAVI (ANHUI) MEDICAL TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VILEX IN TENNESSEE, INC
	SUBSTANTIALLY EQUIVALENT	1
VILEX, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	912	912
Break	186	186
Fracture	94	94
Insufficient Information	91	91
Mechanical Problem	84	84
Patient Device Interaction Problem	66	66
Migration	44	44
Material Fragmentation	27	27
Device Markings/Labelling Problem	24	24
Material Deformation	20	20
Appropriate Term/Code Not Available	19	19
Loose or Intermittent Connection	17	17
Patient-Device Incompatibility	16	16
Detachment Of Device Component	15	15
Device Dislodged or Dislocated	14	14
Malposition of Device	14	14
Device-Device Incompatibility	12	12
Loosening of Implant Not Related to Bone-Ingrowth	11	11
Mechanical Jam	11	11
Unintended Movement	9	9
Bent	9	9
Dull, Blunt	9	9
Detachment of Device or Device Component	8	8
Entrapment of Device	8	8
Inadequacy of Device Shape and/or Size	8	8
Crack	6	6
Device Operates Differently Than Expected	5	5
Difficult to Remove	5	5
Naturally Worn	5	5
Device Slipped	5	5
Packaging Problem	4	4
Physical Resistance/Sticking	4	4
Defective Component	4	4
Contamination	4	4
Product Quality Problem	4	4
No Apparent Adverse Event	3	3
Material Twisted/Bent	3	3
Component Missing	3	3
Contamination /Decontamination Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Material Split, Cut or Torn	3	3
Loss of Osseointegration	3	3
Human-Device Interface Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Material Integrity Problem	3	3
Fitting Problem	2	2
Protective Measures Problem	2	2
Device Packaging Compromised	2	2
Separation Failure	2	2
Difficult to Advance	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	478	478
Injury	200	200
No Code Available	150	150
No Known Impact Or Consequence To Patient	125	125
Post Operative Wound Infection	121	121
No Clinical Signs, Symptoms or Conditions	119	119
Bacterial Infection	109	109
No Information	65	65
Non-union Bone Fracture	60	60
Device Embedded In Tissue or Plaque	59	59
Inflammation	54	54
Failure of Implant	51	51
Pain	48	48
Foreign Body In Patient	39	39
Insufficient Information	37	37
No Consequences Or Impact To Patient	32	32
Erythema	24	24
Nerve Damage	23	23
Bone Fracture(s)	23	23
Deformity/ Disfigurement	20	20
Impaired Healing	15	15
Loss of Range of Motion	14	14
Malunion of Bone	12	12
Irritation	12	12
Skin Infection	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Perforation	11	11
Swelling	10	10
Osteomyelitis	10	10
Thrombosis	9	9
Tissue Breakdown	7	7
Purulent Discharge	6	6
Hematoma	6	6
Arthritis	6	6
Discharge	6	6
Tissue Damage	6	6
Ossification	5	5
Cellulitis	5	5
Ambulation Difficulties	5	5
Necrosis	5	5
Hemorrhage/Bleeding	5	5
Joint Dislocation	5	5
Fluid Discharge	5	5
Joint Contracture	5	5
Pulmonary Embolism	4	4
Fall	4	4
Abscess	4	4
Sedation	4	4
Thrombosis/Thrombus	3	3
No Patient Involvement	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Apr-07-2009
2	Musculoskeletal Transplant Foundation, Inc.	II	Jul-24-2015
3	Orthofix Srl	II	Nov-14-2019
4	Orthofix Srl	II	Apr-28-2010
5	Smith & Nephew Inc	II	Jun-06-2012
6	Smith & Nephew Inc	II	Sep-15-2009
7	Zimmer Biomet, Inc.	II	Dec-29-2017