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	188	188
Break	80	80
Loosening of Implant Not Related to Bone-Ingrowth	37	37
Insufficient Information	32	32
Device Dislodged or Dislocated	29	29
Device-Device Incompatibility	19	19
Detachment of Device or Device Component	14	14
Unstable	13	13
Fracture	13	13
Patient Device Interaction Problem	11	11
Naturally Worn	10	10
Material Deformation	7	7
Appropriate Term/Code Not Available	7	7
Noise, Audible	7	7
Migration	5	5
Defective Device	5	5
Unintended Movement	5	5
Material Erosion	5	5
Loss of or Failure to Bond	3	3
Loss of Osseointegration	3	3
Scratched Material	3	3
Material Separation	2	2
Difficult to Insert	2	2
Loose or Intermittent Connection	2	2
Osseointegration Problem	2	2
Packaging Problem	2	2
Improper or Incorrect Procedure or Method	2	2
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
No Apparent Adverse Event	1	1
Mechanical Problem	1	1
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
Failure to Advance	1	1
Separation Failure	1	1
Failure to Cut	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	106	106
Pain	87	87
Insufficient Information	60	60
Failure of Implant	51	51
Unspecified Tissue Injury	26	26
Muscle/Tendon Damage	25	25
Loss of Range of Motion	24	24
Unspecified Infection	23	23
Joint Dislocation	21	21
Bone Fracture(s)	21	21
Subluxation	18	18
Joint Laxity	18	18
Hematoma	14	14
Limited Mobility Of The Implanted Joint	13	13
Erosion	11	11
Fluid Discharge	8	8
Metal Related Pathology	7	7
Osteopenia/ Osteoporosis	7	7
No Information	6	6
No Code Available	6	6
Osteolysis	6	6
Synovitis	6	6
Inflammation	6	6
Muscular Rigidity	5	5
Discomfort	5	5
Wound Dehiscence	5	5
Numbness	5	5
Foreign Body In Patient	4	4
Implant Pain	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Arthritis	4	4
Fall	4	4
Scar Tissue	4	4
Damage to Ligament(s)	3	3
Tissue Damage	3	3
Hypersensitivity/Allergic reaction	3	3
Adhesion(s)	3	3
Thrombosis/Thrombus	3	3
Swelling/ Edema	2	2
No Known Impact Or Consequence To Patient	2	2
Post Operative Wound Infection	2	2
No Patient Involvement	2	2
Inadequate Osseointegration	2	2
Rheumatoid Arthritis	2	2
Anemia	1	1
Ossification	1	1
Pulmonary Embolism	1	1
Abdominal Pain	1	1
Abscess	1	1
Low Blood Pressure/ Hypotension	1	1
Fever	1	1
Cyst(s)	1	1
Purulent Discharge	1	1
Nerve Damage	1	1
Arthralgia	1	1
Non-union Bone Fracture	1	1
Reaction	1	1
Swelling	1	1
Tissue Breakdown	1	1
Localized Skin Lesion	1	1