TPLC - Total Product Life Cycle

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Device	prosthesis, elbow, semi-constrained, cemented
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	72	77
Loosening of Implant Not Related to Bone-Ingrowth	38	38
Insufficient Information	13	13
Device Dislodged or Dislocated	12	30
Fracture	11	11
Loss of Osseointegration	7	7
Break	6	6
Naturally Worn	5	5
Appropriate Term/Code Not Available	5	5
Patient Device Interaction Problem	4	4
Detachment of Device or Device Component	4	4
Use of Device Problem	4	4
Loss of or Failure to Bond	3	3
Osseointegration Problem	3	3
Migration	3	3
Unintended Movement	3	3
Inaccurate Information	2	2
Migration or Expulsion of Device	2	2
Device Slipped	1	1
Unstable	1	1
Improper or Incorrect Procedure or Method	1	1
Degraded	1	1
Material Erosion	1	1
Mechanical Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	28	32
Failure of Implant	25	25
Insufficient Information	23	41
Implant Pain	20	20
Pain	20	20
Loss of Range of Motion	16	16
No Information	15	15
Joint Laxity	10	11
No Code Available	9	9
Bone Fracture(s)	8	8
No Clinical Signs, Symptoms or Conditions	8	8
Injury	7	7
Swelling/ Edema	6	6
Post Operative Wound Infection	4	4
Fluid Discharge	4	4
No Known Impact Or Consequence To Patient	4	4
Ossification	4	4
Bacterial Infection	4	4
Discomfort	4	4
Tissue Damage	3	3
Inflammation	3	3
Inadequate Osseointegration	3	3
Joint Dislocation	3	3
Osteolysis	3	3
Reaction	2	2
Post Traumatic Wound Infection	2	2
Foreign Body In Patient	2	2
Limb Fracture	2	2
Neuropathy	2	2
No Consequences Or Impact To Patient	2	2
Cyst(s)	2	2
Fall	1	1
Foreign Body Reaction	1	1
Wound Dehiscence	1	1
Erosion	1	1
Adhesion(s)	1	1
Rheumatoid Arthritis	1	1
Scar Tissue	1	1
Unspecified Tissue Injury	1	1
Device Embedded In Tissue or Plaque	1	1
Impaired Healing	1	1