TPLC - Total Product Life Cycle

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Device	prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Product Code	MBF
Regulation Number	888.3670
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET MANUFACTUTING CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET ORTHOPEDICS LLC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	3
FOURNITURES HOSPITALIERES INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	1
IGNITE ORTHOPEDICS LLC
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE S.P.A
	SUBSTANTIALLY EQUIVALENT	2
LIMACORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	6
SHOULDER INNOVATIONS INC
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA)
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	285	285
Insufficient Information	206	206
Unstable	104	104
Break	85	85
Device Dislodged or Dislocated	59	59
Loosening of Implant Not Related to Bone-Ingrowth	40	40
Migration or Expulsion of Device	28	28
Device-Device Incompatibility	26	26
Fracture	23	23
Appropriate Term/Code Not Available	21	21
Detachment of Device or Device Component	20	20
Noise, Audible	18	18
Naturally Worn	18	18
Packaging Problem	14	14
Patient Device Interaction Problem	12	12
Malposition of Device	11	11
Inadequacy of Device Shape and/or Size	11	11
Migration	9	9
Material Erosion	8	8
Material Deformation	8	8
Detachment Of Device Component	7	7
Difficult to Insert	7	7
Improper or Incorrect Procedure or Method	6	6
Defective Device	6	6
Difficult to Remove	6	6
Mechanical Problem	5	5
Loss of or Failure to Bond	5	5
Unintended Movement	5	5
Loss of Osseointegration	4	4
Scratched Material	4	4
Device Markings/Labelling Problem	3	3
Loose or Intermittent Connection	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Material Separation	3	3
Osseointegration Problem	2	2
Device Operates Differently Than Expected	2	2
Failure to Cut	2	2
Device Packaging Compromised	2	2
Component Missing	2	2
Positioning Failure	2	2
Positioning Problem	2	2
Separation Failure	2	2
Torn Material	2	2
Off-Label Use	2	2
Device Slipped	2	2
Material Twisted/Bent	1	1
Device Damaged by Another Device	1	1
Incorrect Device Or Component Shipped	1	1
Material Too Rigid or Stiff	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	316	316
No Clinical Signs, Symptoms or Conditions	113	113
No Code Available	74	74
Insufficient Information	68	68
No Information	67	67
Limited Mobility Of The Implanted Joint	66	66
Failure of Implant	57	57
Loss of Range of Motion	55	55
Unspecified Infection	54	54
Joint Dislocation	50	50
Tissue Damage	36	36
Bone Fracture(s)	36	36
Unspecified Tissue Injury	32	32
Muscle/Tendon Damage	26	26
Hematoma	20	20
Joint Laxity	19	19
Subluxation	19	19
Numbness	16	16
No Known Impact Or Consequence To Patient	16	16
Erosion	13	13
No Consequences Or Impact To Patient	12	12
Discomfort	12	12
Weakness	12	12
Reaction	10	10
Fall	9	9
Muscular Rigidity	9	9
Fluid Discharge	8	8
Osteolysis	8	8
Synovitis	7	7
Wound Dehiscence	7	7
Scar Tissue	7	7
Osteopenia/ Osteoporosis	7	7
Nerve Damage	7	7
Post Operative Wound Infection	7	7
Metal Related Pathology	7	7
Inflammation	6	6
No Patient Involvement	6	6
Tingling	6	6
Foreign Body In Patient	6	6
Adhesion(s)	5	5
Patient Problem/Medical Problem	5	5
Ossification	5	5
Arthritis	4	4
Fracture, Arm	4	4
Impaired Healing	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Bradycardia	4	4
Swelling	4	4
Foreign Body Reaction	4	4
Implant Pain	4	4