TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTHROSURFACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K181280 Patello-Femoral Wave (Kahuna) Arthroplasty System
BIOMET INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	1
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
TORNIER
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	36	36
Insufficient Information	18	18
Loose or Intermittent Connection	13	13
Loosening of Implant Not Related to Bone-Ingrowth	12	12
Fracture	11	11
Migration or Expulsion of Device	9	9
Break	8	8
Naturally Worn	8	8
Appropriate Term/Code Not Available	7	7
Device Contamination with Chemical or Other Material	6	6
Material Fragmentation	5	5
Noise, Audible	5	5
Nonstandard Device	4	4
Unstable	4	4
Malposition of Device	4	4
Improper or Incorrect Procedure or Method	3	3
Biocompatibility	3	3
Device Dislodged or Dislocated	3	3
Device Contaminated During Manufacture or Shipping	2	2
Device Operates Differently Than Expected	2	2
Patient-Device Incompatibility	2	2
Material Separation	2	2
Failure To Adhere Or Bond	2	2
Loss of or Failure to Bond	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Crack	1	1
Degraded	1	1
Device Slipped	1	1
Metal Shedding Debris	1	1
Off-Label Use	1	1
Mechanical Problem	1	1
Loss of Osseointegration	1	1
Defective Device	1	1
Difficult to Open or Remove Packaging Material	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Material Integrity Problem	1	1
No Pressure	1	1
Osseointegration Problem	1	1
Output Problem	1	1
Unintended Movement	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	46	46
Failure of Implant	24	24
Inadequate Pain Relief	16	16
Unspecified Infection	14	14
No Known Impact Or Consequence To Patient	14	14
No Information	11	11
No Code Available	11	11
Injury	7	7
Swelling	5	5
Insufficient Information	5	5
Device Embedded In Tissue or Plaque	4	4
Loss of Range of Motion	4	4
Joint Swelling	4	4
Arthralgia	3	3
Discomfort	3	3
Ambulation Difficulties	3	3
Osteolysis	3	3
Implant Pain	3	3
Metal Related Pathology	2	2
Post Operative Wound Infection	2	2
Foreign Body In Patient	2	2
Hypersensitivity/Allergic reaction	2	2
Anxiety	2	2
Edema	2	2
Fall	2	2
Foreign Body Reaction	1	1
Bone Fracture(s)	1	1
Hematoma	1	1
Erythema	1	1
Adhesion(s)	1	1
Arthritis	1	1
Scar Tissue	1	1
Muscle Weakness	1	1
Synovitis	1	1
Burning Sensation	1	1
No Consequences Or Impact To Patient	1	1
Complaint, Ill-Defined	1	1
Joint Dislocation	1	1
Patient Problem/Medical Problem	1	1
Skin Tears	1	1
Inadequate Osseointegration	1	1
Alteration In Body Temperature	1	1
Fluid Discharge	1	1
Not Applicable	1	1
Subluxation	1	1
Joint Laxity	1	1
No Clinical Signs, Symptoms or Conditions	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Apr-04-2016
2	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-01-2023
3	Zimmer Biomet, Inc.	II	Mar-14-2018
4	Zimmer Biomet, Inc.	II	Feb-22-2016
5	Zimmer, Inc.	II	Aug-26-2014
6	Zimmer, Inc.	II	Oct-25-2013