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	2
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	36	36
Break	34	34
Adverse Event Without Identified Device or Use Problem	24	24
Appropriate Term/Code Not Available	21	21
Fracture	13	13
Migration or Expulsion of Device	8	8
Mechanical Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Difficult to Insert	4	4
Device-Device Incompatibility	3	3
Device Slipped	2	2
Delivered as Unsterile Product	2	2
Difficult To Position	2	2
Migration	2	2
Connection Problem	2	2
Separation Failure	1	1
Difficult to Advance	1	1
Unintended Movement	1	1
Positioning Problem	1	1
Use of Device Problem	1	1
Failure to Align	1	1
Device Packaging Compromised	1	1
Bent	1	1
Material Deformation	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Operates Differently Than Expected	1	1
Corroded	1	1
Device Issue	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1
Detachment Of Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Information	34	34
No Code Available	26	26
No Consequences Or Impact To Patient	19	19
Pain	18	18
No Known Impact Or Consequence To Patient	16	16
Failure of Implant	14	14
Non-union Bone Fracture	10	10
Unspecified Infection	8	8
No Clinical Signs, Symptoms or Conditions	8	8
Injury	8	8
Device Embedded In Tissue or Plaque	8	8
Bone Fracture(s)	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hematoma	4	4
Osteolysis	4	4
Not Applicable	3	3
No Patient Involvement	3	3
Impaired Healing	2	2
Joint Dislocation	2	2
Foreign Body In Patient	2	2
Missing Value Reason	2	2
Complaint, Ill-Defined	1	1
Arthralgia	1	1
Hip Fracture	1	1
Emotional Changes	1	1
Cardiac Arrest	1	1
Insufficient Information	1	1
Sedation	1	1
Calcium Deposits/Calcification	1	1
Ambulation Difficulties	1	1