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
1. K193029 CONQUEST FN
SMITH & NEPHEW INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K193029 CONQUEST FN

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	23	23
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
Delivered as Unsterile Product	2	2
Difficult To Position	2	2
Connection Problem	2	2
Device Slipped	2	2
Use of Device Problem	1	1
Device Issue	1	1
Tear, Rip or Hole in Device Packaging	1	1
Failure to Align	1	1
Separation Failure	1	1
Deformation Due to Compressive Stress	1	1
Device Operates Differently Than Expected	1	1
Device Packaging Compromised	1	1
Bent	1	1
Product Quality Problem	1	1
Detachment Of Device Component	1	1
Corroded	1	1
Difficult to Advance	1	1
Material Deformation	1	1
Mechanical Jam	1	1
Migration	1	1
Positioning Problem	1	1
Unintended Movement	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	17	17
No Known Impact Or Consequence To Patient	16	16
Failure of Implant	14	14
Non-union Bone Fracture	10	10
Injury	8	8
Unspecified Infection	8	8
Device Embedded In Tissue or Plaque	8	8
No Clinical Signs, Symptoms or Conditions	7	7
Bone Fracture(s)	6	6
Hematoma	4	4
Osteolysis	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Not Applicable	3	3
No Patient Involvement	3	3
Foreign Body In Patient	2	2
Missing Value Reason	2	2
Impaired Healing	2	2
Joint Dislocation	2	2
Ambulation Difficulties	1	1
Hip Fracture	1	1
Arthralgia	1	1
Sedation	1	1
Calcium Deposits/Calcification	1	1
Cardiac Arrest	1	1
Emotional Changes	1	1
Complaint, Ill-Defined	1	1
Insufficient Information	1	1