TPLC - Total Product Life Cycle

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Device	prosthesis, elbow, constrained, cemented
Regulation Description	Elbow joint metal/polymer constrained cemented prosthesis.
Product Code	JDC
Regulation Number	888.3150
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	473	533
Loosening of Implant Not Related to Bone-Ingrowth	156	186
Appropriate Term/Code Not Available	80	80
Fracture	79	79
Naturally Worn	43	44
Insufficient Information	40	42
Unstable	35	35
Device Dislodged or Dislocated	34	34
Loose or Intermittent Connection	30	30
Detachment of Device or Device Component	28	30
Patient Device Interaction Problem	16	16
Migration	10	10
Break	8	8
Material Erosion	7	7
Malposition of Device	6	6
Unintended Movement	5	5
No Apparent Adverse Event	5	5
Degraded	4	4
Use of Device Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Difficult to Insert	3	3
Migration or Expulsion of Device	3	6
Mechanical Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Osseointegration Problem	3	3
Loss of Osseointegration	3	3
Noise, Audible	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Peeled/Delaminated	2	2
Packaging Problem	2	2
Material Protrusion/Extrusion	2	2
Expulsion	2	2
Device Markings/Labelling Problem	1	1
Patient-Device Incompatibility	1	1
Material Integrity Problem	1	1
Positioning Problem	1	1
Crack	1	1
Material Fragmentation	1	1
Component Missing	1	1
Off-Label Use	1	1
Failure to Osseointegrate	1	1
Misconnection	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Slipped	1	1
Device Reprocessing Problem	1	1
Difficult to Open or Close	1	1
Flaked	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	191	199
Joint Laxity	180	181
Insufficient Information	163	174
Unspecified Infection	139	179
Bone Fracture(s)	81	84
Pain	76	81
No Clinical Signs, Symptoms or Conditions	42	42
Loss of Range of Motion	41	42
Joint Dislocation	34	34
Implant Pain	25	25
Osteolysis	16	16
Swelling/ Edema	14	14
Metal Related Pathology	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Peripheral Nervous Injury	12	32
Fall	12	12
Limb Fracture	11	11
Osteopenia/ Osteoporosis	11	11
Muscle/Tendon Damage	9	9
Numbness	9	9
Impaired Healing	9	9
Hematoma	9	9
Bacterial Infection	8	8
Ossification	8	8
Nerve Damage	8	9
Wound Dehiscence	7	7
Scar Tissue	7	7
Post Operative Wound Infection	7	7
Joint Contracture	6	10
Inadequate Osseointegration	6	6
Adhesion(s)	6	6
Malunion of Bone	5	5
Foreign Body In Patient	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Muscle Weakness	5	5
Hypersensitivity/Allergic reaction	4	4
Non-union Bone Fracture	3	3
Nodule	3	3
Synovitis	3	4
Seroma	2	2
Paresthesia	2	2
Necrosis	2	2
Unequal Limb Length	2	4
Decreased Sensitivity	2	2
Rheumatoid Arthritis	2	2
Inflammation	2	2
Perforation	2	2
Tissue Breakdown	2	2
Paralysis	1	1
No Known Impact Or Consequence To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Limacorporate S.p.A	II	Mar-16-2023