TPLC - Total Product Life Cycle

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Device	prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Product Code	KRR
Regulation Number	888.3540
Device Class	2

Premarket Reviews
Manufacturer	Decision
EPISURF MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
OVERTURE RESURFACING INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9	9
Loosening of Implant Not Related to Bone-Ingrowth	9	9
Fracture	7	7
Migration or Expulsion of Device	5	5
Naturally Worn	5	5
Loose or Intermittent Connection	4	4
Break	3	3
Unstable	3	3
Biocompatibility	3	3
Insufficient Information	3	3
Appropriate Term/Code Not Available	3	3
Noise, Audible	3	3
Patient Device Interaction Problem	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Dislodged or Dislocated	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1
Output Problem	1	1
Crack	1	1
Degraded	1	1
Material Fragmentation	1	1
Loss of or Failure to Bond	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	24	24
Failure of Implant	13	13
Inadequate Pain Relief	6	6
Unspecified Infection	4	4
Loss of Range of Motion	4	4
Arthralgia	3	3
Osteolysis	3	3
Implant Pain	3	3
Metal Related Pathology	2	2
Ambulation Difficulties	2	2
Anxiety	2	2
Hypersensitivity/Allergic reaction	2	2
Injury	2	2
Discomfort	1	1
No Code Available	1	1
Subluxation	1	1
Joint Laxity	1	1
Synovitis	1	1
Muscle Weakness	1	1
Adhesion(s)	1	1
Edema	1	1
Fall	1	1
Foreign Body Reaction	1	1
Bone Fracture(s)	1	1
Joint Swelling	1	1
Joint Dislocation	1	1
Insufficient Information	1	1
No Clinical Signs, Symptoms or Conditions	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-01-2023