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TPLC
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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
MDR Year
MDR Reports
MDR Events
2014
26
26
2015
18
18
2016
14
14
2017
15
15
2018
14
14
2019
15
15
2020
6
6
2021
8
8
2022
9
9
2023
12
12
2024
17
17
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
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