TPLC - Total Product Life Cycle

show TPLC since

Device	device, fixation, proximal femoral, implant
Product Code	JDO
Regulation Number	888.3030
Device Class	2

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	30	30
Break	24	24
Appropriate Term/Code Not Available	21	21
Adverse Event Without Identified Device or Use Problem	21	21
Fracture	9	9
Mechanical Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Difficult to Insert	4	4
Device-Device Incompatibility	3	3
Migration or Expulsion of Device	2	2
Connection Problem	2	2
Delivered as Unsterile Product	2	2
Difficult To Position	2	2
Migration	2	2
Positioning Problem	1	1
Separation Failure	1	1
Difficult to Advance	1	1
Unintended Movement	1	1
Use of Device Problem	1	1
Failure to Align	1	1
Device Packaging Compromised	1	1
Device Issue	1	1
Corroded	1	1
Mechanical Jam	1	1
Material Deformation	1	1
Bent	1	1
Tear, Rip or Hole in Device Packaging	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Information	29	29
No Consequences Or Impact To Patient	19	19
No Code Available	18	18
Pain	17	17
No Known Impact Or Consequence To Patient	12	12
No Clinical Signs, Symptoms or Conditions	8	8
Injury	8	8
Non-union Bone Fracture	6	6
Unspecified Infection	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hematoma	4	4
Bone Fracture(s)	4	4
Osteolysis	4	4
Device Embedded In Tissue or Plaque	4	4
Not Applicable	3	3
No Patient Involvement	3	3
Joint Dislocation	2	2
Failure of Implant	2	2
Foreign Body In Patient	2	2
Missing Value Reason	2	2
Impaired Healing	1	1
Arthralgia	1	1
Hip Fracture	1	1
Emotional Changes	1	1
Cardiac Arrest	1	1
Insufficient Information	1	1
Calcium Deposits/Calcification	1	1
Ambulation Difficulties	1	1