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	222	227
Osseointegration Problem	66	74
Unstable	46	55
Loss of Osseointegration	35	35
Fracture	24	24
Loosening of Implant Not Related to Bone-Ingrowth	22	22
Break	20	20
Device Dislodged or Dislocated	17	35
Patient Device Interaction Problem	11	11
Insufficient Device Problem Information	5	5
Positioning Failure	4	4
Migration	4	4
Use of Device Problem	4	4
Naturally Worn	3	3
Detachment of Device or Device Component	3	3
Unintended Movement	3	3
Inaccurate Information	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Malposition of Device	2	2
No Apparent Adverse Event	2	2
Improper or Incorrect Procedure or Method	1	1
Material Erosion	1	1
Nonstandard Device	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	93	97
Inadequate Osseointegration	73	81
Joint Laxity	53	62
Insufficient Information	52	70
Bone Fracture(s)	50	51
Implant Pain	37	37
Loss of Range of Motion	30	30
Failure of Implant	26	26
Peripheral Nervous Injury	20	20
Osteolysis	19	19
Medical device site infection	19	19
Swelling/ Edema	17	17
Pain	14	14
No Clinical Signs, Symptoms or Conditions	12	12
Discomfort	11	11
Joint Dislocation	10	10
Limb Fracture	6	6
Fall	5	5
Wound Dehiscence	5	5
Abscess	5	5
Metal Related Pathology	5	5
Muscle Weakness/Atrophy	4	4
Bacterial Infection	4	4
Post Operative Wound Infection	4	4
Neuropathy	4	4
Fluid Discharge	4	4
Joint Impingement	4	4
Inadequate Pain Relief	4	4
Foreign Body In Patient	3	3
Fever	3	3
Sepsis	3	3
Skin Inflammation/ Irritation	3	3
Inflammation	3	3
Wound Infection	2	2
Extraskeletal ossification	2	2
Loss of fracture reduction	2	2
Cyst(s)	2	2
Nerve Damage	2	2
Rheumatoid Arthritis	1	1
Erosion	1	1
Unspecified Tissue Injury	1	1
Impaired Healing	1	1
Muscle/Tendon Damage	1	1