TPLC - Total Product Life Cycle

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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	73	73
Insufficient Information	22	22
Patient Device Interaction Problem	13	13
Adverse Event Without Identified Device or Use Problem	9	9
Break	6	6
Fracture	5	5
Device Slipped	5	5
Loose or Intermittent Connection	4	4
Device Operates Differently Than Expected	4	4
Delivered as Unsterile Product	4	4
Leak/Splash	3	3
Entrapment of Device	3	3
Failure to Osseointegrate	2	2
Packaging Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Migration	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Difficult To Position	1	1
Difficult to Remove	1	1
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1
Loss of or Failure to Bond	1	1
Nonstandard Device	1	1
Device Expiration Issue	1	1
Material Fragmentation	1	1
Detachment Of Device Component	1	1
Crack	1	1
Degraded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Osteolysis	69	69
Tissue Damage	36	36
Therapeutic Response, Decreased	25	25
No Clinical Signs, Symptoms or Conditions	9	9
No Code Available	6	6
No Consequences Or Impact To Patient	6	6
Failure of Implant	5	5
Unspecified Infection	5	5
Device Embedded In Tissue or Plaque	4	4
Osteopenia/ Osteoporosis	3	3
Bone Fracture(s)	3	3
No Known Impact Or Consequence To Patient	3	3
Cardiac Arrest	2	2
Pain	2	2
Foreign Body In Patient	2	2
No Information	2	2
Injury	1	1
Hip Fracture	1	1
Local Reaction	1	1
Inflammation	1	1
Death	1	1
Bacterial Infection	1	1
Implant Pain	1	1
Swelling/ Edema	1	1
Insufficient Information	1	1