TPLC - Total Product Life Cycle

• Device: mesh, surgical, acetabular, hip, prosthesis
• Product Code: JDJ
• Regulation Number: 878.3300
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	15	15
2015	12	12
2016	5	5
2017	2	2
2018	15	15
2019	34	34
2020	14	14
2021	14	14
2022	8	8
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	40	40
Insufficient Information	21	21
Loss of Osseointegration	18	18
Fracture	14	14
Appropriate Term/Code Not Available	11	11
Osseointegration Problem	10	10
Migration	8	8
Device Dislodged or Dislocated	5	5
Naturally Worn	2	2
Break	1	1
Migration or Expulsion of Device	1	1
Unintended Movement	1	1
Difficult to Remove	1	1
Failure To Adhere Or Bond	1	1
Positioning Failure	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	42	42
Unspecified Infection	39	39
Pain	39	39
Inadequate Osseointegration	17	17
Discomfort	17	17
Insufficient Information	13	13
Host-Tissue Reaction	12	12
Thrombosis	9	9
Limited Mobility Of The Implanted Joint	8	8
Joint Laxity	8	8
Tissue Damage	8	8
Physical Asymmetry	8	8
Pulmonary Embolism	8	8
Adhesion(s)	7	7
Scar Tissue	7	7
Injury	3	3
Failure of Implant	2	2
No Information	2	2
Bone Fracture(s)	2	2
Foreign Body Reaction	2	2
Joint Dislocation	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Hematoma	1	1
Inflammation	1	1
No Known Impact Or Consequence To Patient	1	1
Foreign Body In Patient	1	1
Hemorrhage/Bleeding	1	1