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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
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
MDR Year
MDR Reports
MDR Events
2019
15
15
2020
6
6
2021
8
8
2022
9
9
2023
12
12
2024
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
17
17
Loosening of Implant Not Related to Bone-Ingrowth
12
12
Fracture
9
9
Break
5
5
Migration or Expulsion of Device
5
5
Naturally Worn
5
5
Loose or Intermittent Connection
4
4
Unstable
3
3
Insufficient Information
3
3
Appropriate Term/Code Not Available
3
3
Biocompatibility
3
3
Noise, Audible
3
3
Malposition of Device
2
2
Device Dislodged or Dislocated
2
2
Output Problem
1
1
Crack
1
1
Patient-Device Incompatibility
1
1
Defective Device
1
1
Patient Device Interaction Problem
1
1
Degraded
1
1
Material Fragmentation
1
1
Material Separation
1
1
Detachment of Device or Device Component
1
1
Connection Problem
1
1
Loss of or Failure to Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
27
27
Failure of Implant
23
23
Unspecified Infection
6
6
Insufficient Information
6
6
Inadequate Pain Relief
6
6
Loss of Range of Motion
4
4
Arthralgia
3
3
Inadequate Osseointegration
3
3
Implant Pain
3
3
Osteolysis
3
3
Hypersensitivity/Allergic reaction
2
2
Metal Related Pathology
2
2
Injury
2
2
Discomfort
2
2
Anxiety
2
2
Ambulation Difficulties
2
2
Joint Dislocation
1
1
Sepsis
1
1
No Code Available
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Adhesion(s)
1
1
Bone Fracture(s)
1
1
Muscle Weakness
1
1
Synovitis
1
1
Edema
1
1
Cellulitis
1
1
Foreign Body Reaction
1
1
Joint Swelling
1
1
Fall
1
1
Subluxation
1
1
Joint Laxity
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-01-2023
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