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	136	136
Insufficient Information	51	51
Loosening of Implant Not Related to Bone-Ingrowth	31	31
Break	27	27
Device Dislodged or Dislocated	24	24
Unstable	20	20
Detachment of Device or Device Component	14	14
Fracture	14	14
Migration or Expulsion of Device	8	8
Migration	7	7
Packaging Problem	7	7
Appropriate Term/Code Not Available	7	7
Noise, Audible	6	6
Naturally Worn	6	6
Material Erosion	5	5
Patient Device Interaction Problem	5	5
Unintended Movement	4	4
Malposition of Device	4	4
Loss of Osseointegration	3	3
Device-Device Incompatibility	3	3
Improper or Incorrect Procedure or Method	2	2
Defective Device	2	2
Device Markings/Labelling Problem	2	2
Detachment Of Device Component	2	2
Difficult to Insert	2	2
Loose or Intermittent Connection	2	2
Inadequacy of Device Shape and/or Size	2	2
Positioning Problem	2	2
Device Slipped	1	1
Difficult To Position	1	1
Difficult to Remove	1	1
Material Separation	1	1
Shipping Damage or Problem	1	1
Corroded	1	1
Positioning Failure	1	1
Disassembly	1	1
Material Disintegration	1	1
Failure To Adhere Or Bond	1	1
Material Fragmentation	1	1
Device Packaging Compromised	1	1
Tear, Rip or Hole in Device Packaging	1	1
Failure to Advance	1	1
Separation Failure	1	1
Osseointegration Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Material Twisted/Bent	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	103	103
Failure of Implant	46	46
No Clinical Signs, Symptoms or Conditions	33	33
Loss of Range of Motion	29	29
No Information	27	27
Insufficient Information	23	23
Limited Mobility Of The Implanted Joint	22	22
Unspecified Infection	20	20
Joint Dislocation	18	18
Bone Fracture(s)	17	17
Muscle/Tendon Damage	17	17
No Code Available	14	14
Tissue Damage	14	14
Subluxation	11	11
Joint Laxity	8	8
Metal Related Pathology	6	6
Numbness	6	6
Osteolysis	6	6
Hematoma	6	6
Erosion	6	6
Wound Dehiscence	5	5
Reaction	5	5
Inflammation	5	5
Scar Tissue	5	5
Post Operative Wound Infection	5	5
Foreign Body In Patient	5	5
No Known Impact Or Consequence To Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Thrombosis/Thrombus	3	3
No Patient Involvement	3	3
Damage to Ligament(s)	3	3
Nerve Damage	3	3
Syncope	3	3
Adhesion(s)	3	3
Bradycardia	3	3
Fall	3	3
Abscess	2	2
Hypersensitivity/Allergic reaction	2	2
Arthritis	2	2
Synovitis	2	2
No Consequences Or Impact To Patient	2	2
Fracture, Arm	2	2
Muscular Rigidity	2	2
Ambulation Difficulties	2	2
Blood Loss	2	2
Osteopenia/ Osteoporosis	2	2
Unspecified Tissue Injury	2	2
Implant Pain	1	1
Swelling/ Edema	1	1
Sleep Dysfunction	1	1
Inadequate Osseointegration	1	1
Tissue Breakdown	1	1
Not Applicable	1	1
Patient Problem/Medical Problem	1	1
Swelling	1	1
Arthralgia	1	1
Non-union Bone Fracture	1	1
Discomfort	1	1
Rheumatoid Arthritis	1	1
Bacterial Infection	1	1
Anemia	1	1
Abdominal Pain	1	1
Ossification	1	1
Pulmonary Embolism	1	1
Low Blood Pressure/ Hypotension	1	1
Purulent Discharge	1	1