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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	206	206
Break	85	85
Loosening of Implant Not Related to Bone-Ingrowth	40	40
Insufficient Information	32	32
Device Dislodged or Dislocated	29	29
Device-Device Incompatibility	24	24
Naturally Worn	15	15
Detachment of Device or Device Component	14	14
Unstable	13	13
Fracture	13	13
Patient Device Interaction Problem	12	12
Material Deformation	8	8
Noise, Audible	7	7
Appropriate Term/Code Not Available	7	7
Material Erosion	5	5
Unintended Movement	5	5
Defective Device	5	5
Migration	5	5
Loss of or Failure to Bond	4	4
Difficult to Insert	4	4
Loss of Osseointegration	3	3
Scratched Material	3	3
Osseointegration Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Loose or Intermittent Connection	2	2
Material Separation	2	2
Packaging Problem	2	2
Failure to Cut	2	2
Delivered as Unsterile Product	1	1
Positioning Failure	1	1
Shipping Damage or Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Fragmentation	1	1
No Apparent Adverse Event	1	1
Difficult to Remove	1	1
Positioning Problem	1	1
Failure to Advance	1	1
Material Integrity Problem	1	1
Patient-Device Incompatibility	1	1
Separation Failure	1	1
Component Incompatible	1	1
Device Markings/Labelling Problem	1	1
Malposition of Device	1	1
Off-Label Use	1	1
Migration or Expulsion of Device	1	1
Mechanical Problem	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	113	113
Pain	94	94
Insufficient Information	68	68
Failure of Implant	52	52
Unspecified Tissue Injury	32	32
Muscle/Tendon Damage	25	25
Unspecified Infection	25	25
Loss of Range of Motion	24	24
Bone Fracture(s)	22	22
Joint Dislocation	21	21
Joint Laxity	18	18
Subluxation	18	18
Hematoma	14	14
Limited Mobility Of The Implanted Joint	13	13
Erosion	12	12
Fluid Discharge	8	8
Osteolysis	8	8
Metal Related Pathology	7	7
Osteopenia/ Osteoporosis	7	7
No Code Available	6	6
No Information	6	6
Inflammation	6	6
Synovitis	6	6
Discomfort	6	6
Wound Dehiscence	5	5
Muscular Rigidity	5	5
Numbness	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Impaired Healing	4	4
Implant Pain	4	4
Scar Tissue	4	4
Fall	4	4
Foreign Body In Patient	4	4
Arthritis	4	4
Hypersensitivity/Allergic reaction	3	3
Tissue Damage	3	3
Adhesion(s)	3	3
Damage to Ligament(s)	3	3
Thrombosis/Thrombus	3	3
Swelling/ Edema	2	2
No Patient Involvement	2	2
No Known Impact Or Consequence To Patient	2	2
Post Operative Wound Infection	2	2
Inadequate Osseointegration	2	2
Rheumatoid Arthritis	2	2
Swelling	1	1
Nerve Damage	1	1
Fever	1	1
Abscess	1	1
Reaction	1	1