TPLC - Total Product Life Cycle

• Device: device, fixation, proximal femoral, implant
• Regulation Description: Single/multiple component metallic bone fixation appliances and accessories.
• Product Code: JDO
• Regulation Number: 888.3030
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
OSTEOCENTRIC TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
OSTEOCENTRIC TECHNOLOGIES D.B.A. OSTEOCENTRIC TRAUMA
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	10	10
2020	19	19
2021	10	10
2022	3	3
2023	5	5
2024	2	2
2025	1	1
2026	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	15	15
Break	15	15
Mechanical Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Device-Device Incompatibility	3	3
Connection Problem	2	2
Fracture	2	2
Migration	2	2
Insufficient Device Problem Information	2	2
Appropriate Device Problem Term/Code Not Available	1	1
Detachment of Device or Device Component	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	10	10
No Clinical Signs, Symptoms or Conditions	9	9
No Code Available	8	8
Injury	7	7
Bone Fracture(s)	4	4
Nonunion/Delayed-union Bone Fracture	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
No Known Impact Or Consequence To Patient	3	3
Pain	3	3
Insufficient Information	2	2
Unspecified Infection	2	2
Not Applicable	1	1
Calcium Deposits/Calcification	1	1
No Patient Involvement	1	1
Ambulation or Postural Difficulties	1	1
Emotional Changes	1	1
Failure of Implant	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Zimmer Biomet, Inc.	II	Jan-29-2020