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	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Device-Device Incompatibility	2	2
Mechanical Problem	2	2
Insufficient Information	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Migration	2	2
Migration or Expulsion of Device	1	1
Positioning Problem	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Appropriate Term/Code Not Available	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9	9
No Consequences Or Impact To Patient	9	9
Injury	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Code Available	4	4
Bone Fracture(s)	4	4
Non-union Bone Fracture	4	4
Pain	3	3
Unspecified Infection	2	2
Emotional Changes	1	1
Failure of Implant	1	1
No Known Impact Or Consequence To Patient	1	1
Insufficient Information	1	1
Ambulation Difficulties	1	1

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