TPLC - Total Product Life Cycle

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Device	prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Regulation Description	Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
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	218	218
Break	99	99
Loosening of Implant Not Related to Bone-Ingrowth	46	46
Device Dislodged or Dislocated	32	32
Device-Device Incompatibility	29	29
Insufficient Information	20	20
Naturally Worn	20	20
Fracture	19	19
Patient Device Interaction Problem	12	12
Material Deformation	12	12
Detachment of Device or Device Component	11	11
Unstable	9	9
Loss of or Failure to Bond	6	6
Migration	6	6
Material Erosion	5	5
Osseointegration Problem	4	4
Defective Device	4	4
Scratched Material	4	4
Difficult to Insert	4	4
Noise, Audible	3	3
Unintended Movement	3	3
Appropriate Term/Code Not Available	3	3
Loss of Osseointegration	2	2
Improper or Incorrect Procedure or Method	2	2
Loose or Intermittent Connection	2	2
Material Separation	2	2
Failure to Cut	2	2
Packaging Problem	1	1
Delivered as Unsterile Product	1	1
Tear, Rip or Hole in Device Packaging	1	1
No Apparent Adverse Event	1	1
Positioning Failure	1	1
Material Fragmentation	1	1
Failure to Advance	1	1
Difficult to Remove	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Component Incompatible	1	1
Patient-Device Incompatibility	1	1
Separation Failure	1	1
Device Markings/Labelling Problem	1	1
Malposition of Device	1	1
Off-Label Use	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	123	123
Insufficient Information	83	83
Pain	82	82
Failure of Implant	64	64
Unspecified Tissue Injury	51	51
Joint Dislocation	27	27
Bone Fracture(s)	26	26
Muscle/Tendon Damage	25	25
Loss of Range of Motion	24	24
Unspecified Infection	23	23
Joint Laxity	20	20
Subluxation	19	19
Hematoma	13	13
Erosion	12	12
Metal Related Pathology	12	12
Fluid Discharge	12	12
Osteolysis	8	8
Osteopenia/ Osteoporosis	7	7
Thrombosis/Thrombus	7	7
Inflammation	6	6
Synovitis	6	6
Fall	5	5
Discomfort	5	5
Pulmonary Embolism	4	4
Arthritis	4	4
Impaired Healing	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Inadequate Osseointegration	4	4
Limited Mobility Of The Implanted Joint	4	4
Adhesion(s)	4	4
Implant Pain	4	4
Scar Tissue	4	4
Foreign Body In Patient	4	4
Muscular Rigidity	4	4
Wound Dehiscence	3	3
Hypersensitivity/Allergic reaction	3	3
Swelling/ Edema	2	2
No Known Impact Or Consequence To Patient	2	2
Rheumatoid Arthritis	2	2
Numbness	1	1
Nerve Damage	1	1
Fever	1	1
Ossification	1	1
Localized Skin Lesion	1	1
Purulent Discharge	1	1
Non-union Bone Fracture	1	1
Cyst(s)	1	1
No Code Available	1	1
Arthralgia	1	1
Damage to Ligament(s)	1	1