TPLC - Total Product Life Cycle

• Device: prosthesis, hip, hemi-, femoral, metal ball
• Product Code: LZY
• Regulation Number: 888.3360
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2017	72	72
2018	67	67
2019	59	59
2020	79	79
2021	59	59
2022	65	65

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	234	234
Insufficient Information	89	89
Device Dislodged or Dislocated	51	51
Appropriate Term/Code Not Available	8	8
Naturally Worn	6	6
Break	3	3
Migration	3	3
Inadequacy of Device Shape and/or Size	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Deformation	2	2
Improper or Incorrect Procedure or Method	1	1
Fracture	1	1
Material Twisted/Bent	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	163	163
No Code Available	141	141
Pain	124	124
Joint Dislocation	53	53
Not Applicable	23	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	21
No Clinical Signs, Symptoms or Conditions	9	9
Joint Laxity	7	7
No Information	6	6
Foreign Body Reaction	6	6
Hematoma	6	6
Discomfort	6	6
Injury	4	4
Fall	4	4
Fluid Discharge	4	4
Insufficient Information	3	3
Failure of Implant	2	2
No Consequences Or Impact To Patient	2	2
Post Operative Wound Infection	2	2
Tissue Damage	2	2
Joint Disorder	1	1
Phlebitis	1	1
Seroma	1	1
Stroke/CVA	1	1
Erosion	1	1
Hypersensitivity/Allergic reaction	1	1
Thrombosis	1	1
Test Result	1	1
Pneumonia	1	1
Pocket Erosion	1	1
Adhesion(s)	1	1
Cardiac Arrest	1	1
Embolism	1	1
Heart Failure/Congestive Heart Failure	1	1
Wound Dehiscence	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DePuy Orthopaedics, Inc.	II	Jul-12-2022