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
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	28	28
Insufficient Information	18	18
Loose or Intermittent Connection	13	13
Migration or Expulsion of Device	9	9
Fracture	9	9
Loosening of Implant Not Related to Bone-Ingrowth	9	9
Naturally Worn	8	8
Break	7	7
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
Device Dislodged or Dislocated	3	3
Improper or Incorrect Procedure or Method	3	3
Biocompatibility	3	3
Device Operates Differently Than Expected	2	2
Malposition of Device	2	2
Patient-Device Incompatibility	2	2
Device Contaminated During Manufacture or Shipping	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
Material Integrity Problem	1	1
No Pressure	1	1
Osseointegration Problem	1	1
Output Problem	1	1
Unintended Movement	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
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	45	45
Failure of Implant	16	16
Inadequate Pain Relief	16	16
No Known Impact Or Consequence To Patient	14	14
Unspecified Infection	12	12
No Information	11	11
No Code Available	11	11
Injury	7	7
Swelling	5	5
Loss of Range of Motion	4	4
Joint Swelling	4	4
Device Embedded In Tissue or Plaque	4	4
Implant Pain	3	3
Osteolysis	3	3
Arthralgia	3	3
Ambulation Difficulties	3	3
Post Operative Wound Infection	2	2
Foreign Body In Patient	2	2
Anxiety	2	2
Discomfort	2	2
Hypersensitivity/Allergic reaction	2	2
Edema	2	2
Fall	2	2
Metal Related Pathology	2	2
Insufficient Information	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Not Applicable	1	1
Subluxation	1	1
Joint Laxity	1	1
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
Joint Dislocation	1	1
Complaint, Ill-Defined	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

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