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	475	537
Loosening of Implant Not Related to Bone-Ingrowth	145	175
Fracture	66	66
Insufficient Device Problem Information	38	40
Unstable	37	37
Naturally Worn	36	37
Device Dislodged or Dislocated	30	30
Detachment of Device or Device Component	29	31
Patient Device Interaction Problem	20	20
Migration	10	10
Material Erosion	7	7
Malposition of Device	6	6
Unintended Movement	5	5
No Apparent Adverse Event	5	5
Mechanical Problem	4	4
Difficult to Insert	4	4
Use of Device Problem	4	4
Migration or Expulsion of Device	3	6
Inadequacy of Device Shape and/or Size	3	3
Osseointegration Problem	3	3
Noise, Audible	3	3
Break	3	3
Degraded	3	3
Improper or Incorrect Procedure or Method	3	3
Loss of Osseointegration	3	3
Peeled/Delaminated	2	2
Expulsion	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Packaging Problem	2	2
Deformation Due to Compressive Stress	1	1
Device Markings/Labelling Problem	1	1
Difficult to Open or Close	1	1
Material Integrity Problem	1	1
Crack	1	1
Flaked	1	1
Material Fragmentation	1	1
Failure to Osseointegrate	1	1
Component Missing	1	1
Tear, Rip or Hole in Device Packaging	1	1
Damaged Thread	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	192	200
Joint Laxity	191	192
Insufficient Information	167	178
Unspecified Infection	146	186
Bone Fracture(s)	81	84
Pain	78	83
No Clinical Signs, Symptoms or Conditions	43	43
Loss of Range of Motion	41	42
Joint Dislocation	34	34
Aseptic loosening	30	31
Implant Pain	26	26
Osteolysis	16	16
Peripheral Nervous Injury	14	36
Metal Related Pathology	14	14
Swelling/ Edema	14	14
Fall	12	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	12	12
Limb Fracture	11	11
Osteopenia/ Osteoporosis	11	11
Muscle/Tendon Damage	9	9
Medical device site infection	9	21
Impaired Healing	9	9
Numbness	9	9
Hematoma	9	9
Extraskeletal ossification	8	8
Nerve Damage	8	9
Bacterial Infection	8	8
Periprosthetic fracture	8	8
High metal ion levels	8	8
Post Operative Wound Infection	7	7
Wound Dehiscence	7	7
Scar Tissue	7	7
Joint Contracture	6	10
Adhesion(s)	6	6
Inadequate Osseointegration	6	6
Malunion of Bone	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Foreign Body In Patient	5	5
Muscle Weakness/Atrophy	5	5
Hypersensitivity/Allergic reaction	4	4
Loose body in joint	4	4
Synovitis	3	4
Nonunion/Delayed-union Bone Fracture	3	3
Radiolucent Lines	3	3
Nodule	3	3
Inflammation	2	2
Necrosis	2	2
Tissue Breakdown	2	2
Perforation	2	2
Rheumatoid Arthritis	2	2

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