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	177	177
Break	74	74
Loosening of Implant Not Related to Bone-Ingrowth	35	35
Insufficient Information	32	32
Device Dislodged or Dislocated	25	25
Device-Device Incompatibility	16	16
Detachment of Device or Device Component	14	14
Unstable	13	13
Fracture	13	13
Patient Device Interaction Problem	11	11
Naturally Worn	9	9
Appropriate Term/Code Not Available	7	7
Noise, Audible	6	6
Migration	5	5
Unintended Movement	5	5
Defective Device	5	5
Material Deformation	5	5
Material Erosion	5	5
Loss of or Failure to Bond	3	3
Loss of Osseointegration	3	3
Scratched Material	3	3
Osseointegration Problem	2	2
Packaging Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Material Separation	2	2
Loose or Intermittent Connection	2	2
Migration or Expulsion of Device	1	1
Delivered as Unsterile Product	1	1
Off-Label Use	1	1
Difficult to Remove	1	1
Component Incompatible	1	1
Shipping Damage or Problem	1	1
Device Slipped	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Failure to Advance	1	1
Separation Failure	1	1
Failure to Cut	1	1
Tear, Rip or Hole in Device Packaging	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Material Integrity Problem	1	1
Device Markings/Labelling Problem	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	98	98
Pain	82	82
Insufficient Information	52	52
Failure of Implant	50	50
Unspecified Tissue Injury	26	26
Muscle/Tendon Damage	23	23
Unspecified Infection	23	23
Loss of Range of Motion	23	23
Bone Fracture(s)	20	20
Subluxation	18	18
Joint Laxity	18	18
Joint Dislocation	15	15
Hematoma	14	14
Limited Mobility Of The Implanted Joint	13	13
Erosion	10	10
Fluid Discharge	8	8
Metal Related Pathology	7	7
No Information	6	6
No Code Available	6	6
Osteolysis	6	6
Synovitis	6	6
Discomfort	5	5
Numbness	5	5
Muscular Rigidity	5	5
Inflammation	5	5
Wound Dehiscence	5	5
Scar Tissue	4	4
Fall	4	4
Osteopenia/ Osteoporosis	4	4
Implant Pain	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Thrombosis/Thrombus	3	3
Foreign Body In Patient	3	3
Tissue Damage	3	3
Damage to Ligament(s)	3	3
Hypersensitivity/Allergic reaction	2	2
Adhesion(s)	2	2
Arthritis	2	2
Rheumatoid Arthritis	2	2
Post Operative Wound Infection	2	2
No Patient Involvement	2	2
Inadequate Osseointegration	2	2
No Known Impact Or Consequence To Patient	2	2
Tissue Breakdown	1	1
Reaction	1	1
Swelling/ Edema	1	1
Arthralgia	1	1
Non-union Bone Fracture	1	1
Swelling	1	1
Nerve Damage	1	1
Purulent Discharge	1	1
Anemia	1	1
Ossification	1	1
Pulmonary Embolism	1	1
Abdominal Pain	1	1
Abscess	1	1
Low Blood Pressure/ Hypotension	1	1