TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
HOWMEDICA OSTEONICS, DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	14	14
Patient Device Interaction Problem	13	13
Adverse Event Without Identified Device or Use Problem	13	13
Delivered as Unsterile Product	8	8
Fracture	4	4
Break	3	3
Tear, Rip or Hole in Device Packaging	3	3
Improper or Incorrect Procedure or Method	2	2
Loss of Osseointegration	2	2
Entrapment of Device	1	1
Physical Resistance/Sticking	1	1
Crack	1	1
Device Damaged Prior to Use	1	1
Shipping Damage or Problem	1	1
Device Handling Problem	1	1
Migration	1	1
Loose or Intermittent Connection	1	1
Osseointegration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Osteolysis	18	18
No Clinical Signs, Symptoms or Conditions	14	14
Pain	5	5
Unspecified Infection	4	4
Loss of Range of Motion	4	4
Swelling/ Edema	4	4
Inadequate Osseointegration	3	3
Implant Pain	3	3
Insufficient Information	3	3
Failure of Implant	2	2
Bone Fracture(s)	2	2
Device Embedded In Tissue or Plaque	2	2
Metal Related Pathology	1	1
Inflammation	1	1
Cardiac Arrest	1	1
Foreign Body In Patient	1	1
Discomfort	1	1
Bacterial Infection	1	1