TPLC - Total Product Life Cycle

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Device	prosthesis, elbow, semi-constrained, cemented
Regulation Description	Elbow joint metal/polymer semi-constrained cemented prosthesis.
Product Code	JDB
Regulation Number	888.3160
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	144	149
Osseointegration Problem	61	69
Unstable	40	49
Loosening of Implant Not Related to Bone-Ingrowth	30	30
Fracture	24	24
Device Dislodged or Dislocated	22	41
Break	20	20
Loss of Osseointegration	13	13
Patient Device Interaction Problem	11	11
Insufficient Information	7	7
Naturally Worn	5	5
Use of Device Problem	4	4
Detachment of Device or Device Component	4	4
Migration	4	4
Unintended Movement	3	3
Appropriate Term/Code Not Available	3	4
Malposition of Device	2	2
No Apparent Adverse Event	2	2
Inaccurate Information	2	2
Mechanical Problem	1	1
Material Erosion	1	1
Material Integrity Problem	1	1
Degraded	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	77	81
Inadequate Osseointegration	64	72
Joint Laxity	47	56
Bone Fracture(s)	37	38
Implant Pain	37	37
Failure of Implant	34	34
Loss of Range of Motion	34	34
Insufficient Information	31	49
Pain	23	23
Swelling/ Edema	17	17
No Clinical Signs, Symptoms or Conditions	11	11
Osteolysis	11	11
Discomfort	11	11
Joint Dislocation	10	10
Injury	7	7
Limb Fracture	6	6
No Information	6	6
Abscess	5	5
Fall	5	5
Inadequate Pain Relief	4	4
Bacterial Infection	4	4
Metal Related Pathology	4	4
Fluid Discharge	4	4
Post Operative Wound Infection	4	4
Fever	3	3
Foreign Body In Patient	3	3
Ossification	3	3
Inflammation	3	3
Skin Inflammation/ Irritation	3	3
Sepsis	3	3
Post Traumatic Wound Infection	2	2
Cyst(s)	2	2
Reaction	2	2
Neuropathy	2	2
Foreign Body Reaction	1	1
Scar Tissue	1	1
Adhesion(s)	1	1
No Code Available	1	1
Rheumatoid Arthritis	1	1
Wound Dehiscence	1	1
Unspecified Tissue Injury	1	1
Tissue Damage	1	1
Erosion	1	1
Impaired Healing	1	1
Device Embedded In Tissue or Plaque	1	1