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
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
Unstable	4	4
Malposition of Device	4	4
Nonstandard Device	4	4
Improper or Incorrect Procedure or Method	3	3
Device Dislodged or Dislocated	3	3
Biocompatibility	3	3
Device Operates Differently Than Expected	2	2
Material Separation	2	2
Patient-Device Incompatibility	2	2
Device Contaminated During Manufacture or Shipping	2	2
Failure To Adhere Or Bond	2	2
Connection Problem	1	1
Loss of or Failure to Bond	1	1
Loss of Osseointegration	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Patient Device Interaction Problem	1	1
Defective Device	1	1
Mechanical Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Material Integrity Problem	1	1
Off-Label Use	1	1
Output Problem	1	1
Unintended Movement	1	1
Detachment of Device or Device Component	1	1
Crack	1	1
Device Slipped	1	1
Degraded	1	1
Metal Shedding Debris	1	1
No Pressure	1	1
Osseointegration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	47	47
Failure of Implant	24	24
Inadequate Pain Relief	16	16
Unspecified Infection	14	14
No Known Impact Or Consequence To Patient	14	14
No Code Available	11	11
No Information	11	11
Injury	7	7
Insufficient Information	6	6
Swelling	5	5
Device Embedded In Tissue or Plaque	4	4
Inadequate Osseointegration	4	4
Joint Swelling	4	4
Loss of Range of Motion	4	4
Ambulation Difficulties	3	3
Arthralgia	3	3
Osteolysis	3	3
Discomfort	3	3
Implant Pain	3	3
Anxiety	2	2
Fall	2	2
Foreign Body In Patient	2	2
Post Operative Wound Infection	2	2
Edema	2	2
Metal Related Pathology	2	2
Hypersensitivity/Allergic reaction	2	2
Foreign Body Reaction	1	1
Alteration In Body Temperature	1	1
Cellulitis	1	1
Burning Sensation	1	1
Synovitis	1	1
Erythema	1	1
Muscle Weakness	1	1
Hematoma	1	1
Bone Fracture(s)	1	1
Adhesion(s)	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Not Applicable	1	1
Sepsis	1	1
Scar Tissue	1	1
Fluid Discharge	1	1
Subluxation	1	1
Joint Dislocation	1	1
Joint Laxity	1	1
Skin Tears	1	1
No Consequences Or Impact To Patient	1	1
Complaint, Ill-Defined	1	1
Arthritis	1	1
Patient Problem/Medical Problem	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