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TPLC
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Device
prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Description
Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
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
2020
6
6
2021
8
8
2022
9
9
2023
12
12
2024
25
25
2025
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
21
21
Loosening of Implant Not Related to Bone-Ingrowth
10
10
Fracture
9
9
Break
6
6
Migration or Expulsion of Device
5
5
Naturally Worn
3
3
Biocompatibility
3
3
Malposition of Device
2
2
Degraded
2
2
Device Dislodged or Dislocated
2
2
Noise, Audible
2
2
Output Problem
1
1
Crack
1
1
Insufficient Information
1
1
Defective Device
1
1
Patient Device Interaction Problem
1
1
Material Separation
1
1
Detachment of Device or Device Component
1
1
Appropriate Term/Code Not Available
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
Failure of Implant
22
22
Pain
19
19
Insufficient Information
9
9
Unspecified Infection
5
5
Loss of Range of Motion
4
4
Arthralgia
3
3
Inadequate Osseointegration
3
3
Implant Pain
3
3
Osteolysis
3
3
Ambulation Difficulties
3
3
Hypersensitivity/Allergic reaction
2
2
Sepsis
2
2
Metal Related Pathology
2
2
Cellulitis
2
2
Discomfort
2
2
Anxiety
2
2
Inadequate Pain Relief
2
2
Joint Dislocation
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Bone Fracture(s)
1
1
Muscle Weakness
1
1
Synovitis
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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