TPLC - Total Product Life Cycle

• Device: prosthesis, hip, cement restrictor
• Product Code: JDK
• Regulation Number: 878.3300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	2	2
2015	7	7
2016	2	2
2018	1	1
2019	13	13
2020	4	4
2021	3	3
2022	4	4
2023	7	7
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	13	13
Break	10	10
Fracture	9	9
Insufficient Information	4	4
Loss of or Failure to Bond	2	2
Material Deformation	2	2
Material Twisted/Bent	2	2
Naturally Worn	2	2
Loose or Intermittent Connection	2	2
Difficult to Remove	2	2
Connection Problem	2	2
Detachment of Device or Device Component	1	1
Device-Device Incompatibility	1	1
Device Dislodged or Dislocated	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Entrapment of Device	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	10	10
No Consequences Or Impact To Patient	10	10
Unspecified Infection	7	7
No Code Available	7	7
No Clinical Signs, Symptoms or Conditions	7	7
No Information	4	4
Not Applicable	2	2
Foreign Body In Patient	2	2
Obstruction/Occlusion	2	2
Ambulation Difficulties	1	1
Osteolysis	1	1
Burning Sensation	1	1
Host-Tissue Reaction	1	1
Foreign Body Reaction	1	1
Device Embedded In Tissue or Plaque	1	1
Joint Laxity	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Depuy Orthopaedics, Inc.	II	Mar-17-2011
2	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024