Definition: This Type Of Device Is Designed To Allow For Motion Between The Plastic Tibial Bearing And Metal Tibial Baseplate Components Of A Unicompartmental Knee Prosthesis. It Is Intended To Replace Part Of A Knee Joint In Order To Relieve Pain And Restore Kn
| Device Type ID | 4739 |
| Device Name | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NRA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4739 |
| Device | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing |
| Product Code | NRA |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Insufficient Information | 843 |
Migration Or Expulsion Of Device | 205 |
Appropriate Term/Code Not Available | 165 |
Device Dislodged Or Dislocated | 129 |
Adverse Event Without Identified Device Or Use Problem | 126 |
Unstable | 58 |
Fracture | 50 |
Loss Of Or Failure To Bond | 29 |
Loose Or Intermittent Connection | 23 |
Malposition Of Device | 19 |
Noise, Audible | 18 |
Mechanical Problem | 17 |
Material Erosion | 15 |
Naturally Worn | 10 |
Break | 9 |
Detachment Of Device Component | 9 |
Inadequacy Of Device Shape And/or Size | 7 |
Packaging Problem | 7 |
Metal Shedding Debris | 7 |
Bearings | 6 |
Device Operates Differently Than Expected | 5 |
Device Slipped | 5 |
Unintended Movement | 5 |
Off-Label Use | 4 |
Device Packaging Compromised | 4 |
Detachment Of Device Or Device Component | 4 |
Collapse | 4 |
Positioning Problem | 4 |
Tear, Rip Or Hole In Device Packaging | 4 |
Failure To Adhere Or Bond | 3 |
Disassembly | 3 |
Device Markings / Labelling Problem | 3 |
Material Fragmentation | 3 |
Device-Device Incompatibility | 3 |
Device Contamination With Chemical Or Other Material | 2 |
Unsealed Device Packaging | 2 |
Scratched Material | 2 |
Material Rupture | 2 |
Component Falling | 2 |
Entrapment Of Device | 2 |
Use Of Device Problem | 2 |
Inadequate Instructions For Healthcare Professional | 1 |
Screw | 1 |
Component Missing | 1 |
Overcorrection | 1 |
No Apparent Adverse Event | 1 |
Delivered As Unsterile Product | 1 |
Migration | 1 |
Difficult To Remove | 1 |
Failure To Osseointegrate | 1 |
Material Separation | 1 |
Device Handling Problem | 1 |
Component Incompatible | 1 |
Device Subassembly | 1 |
Sticking | 1 |
Fitting Problem | 1 |
| Total Device Problems | 1835 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet U.K., Ltd. | II | Feb-22-2017 |