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	136	141
Osseointegration Problem	54	62
Loosening of Implant Not Related to Bone-Ingrowth	38	38
Unstable	32	41
Fracture	22	22
Device Dislodged or Dislocated	20	38
Break	17	17
Insufficient Information	13	13
Loss of Osseointegration	12	12
Patient Device Interaction Problem	7	7
Naturally Worn	7	7
Appropriate Term/Code Not Available	6	6
Use of Device Problem	4	4
Detachment of Device or Device Component	4	4
Migration	4	4
Unintended Movement	3	3
Loss of or Failure to Bond	3	3
Migration or Expulsion of Device	2	2
Malposition of Device	2	2
Inaccurate Information	2	2
Device Slipped	1	1
Mechanical Problem	1	1
Material Erosion	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Degraded	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	68	72
Inadequate Osseointegration	55	63
Joint Laxity	46	55
Bone Fracture(s)	37	37
Failure of Implant	35	35
Implant Pain	33	33
Insufficient Information	28	46
Loss of Range of Motion	22	22
Pain	20	20
No Information	15	15
Joint Dislocation	10	10
Osteolysis	10	10
No Code Available	9	9
No Clinical Signs, Symptoms or Conditions	9	9
Swelling/ Edema	9	9
Discomfort	9	9
Injury	7	7
Fall	5	5
Inadequate Pain Relief	4	4
Bacterial Infection	4	4
Fluid Discharge	4	4
No Known Impact Or Consequence To Patient	4	4
Ossification	4	4
Post Operative Wound Infection	4	4
Tissue Damage	3	3
Fever	3	3
Inflammation	3	3
Skin Inflammation/ Irritation	3	3
Sepsis	3	3
Foreign Body In Patient	2	2
Post Traumatic Wound Infection	2	2
Cyst(s)	2	2
Reaction	2	2
Limb Fracture	2	2
No Consequences Or Impact To Patient	2	2
Neuropathy	2	2
Foreign Body Reaction	1	1
Scar Tissue	1	1
Adhesion(s)	1	1
Rheumatoid Arthritis	1	1
Unspecified Tissue Injury	1	1
Wound Dehiscence	1	1
Erosion	1	1
Impaired Healing	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Limacorporate S.p.A	II	Dec-20-2024