Definition: This Type Of Device Is Designed To Allow For Motion Between The Plastic Bearing And Metal Baseplate Components Of A Knee Prosthesis. It Is Intended To Replace A Knee Joint In Order To Relieve Pain And Restore Knee Function, For Indications Such As Os
| Device Type ID | 4735 |
| Device Name | Prosthesis, Knee, Patellofemorotibial, 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 | NJL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4735 |
| Device | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
| Product Code | NJL |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Insufficient Information | 1952 |
Loss Of Or Failure To Bond | 1140 |
Adverse Event Without Identified Device Or Use Problem | 289 |
Naturally Worn | 245 |
Migration Or Expulsion Of Device | 224 |
Loose Or Intermittent Connection | 175 |
Appropriate Term/Code Not Available | 168 |
Loss Of Osseointegration | 159 |
Break | 108 |
Fracture | 61 |
Failure To Adhere Or Bond | 58 |
Malposition Of Device | 56 |
Noise, Audible | 36 |
Migration | 35 |
Loosening Of Implant Not Related To Bone-Ingrowth | 31 |
Unstable | 29 |
Device Dislodged Or Dislocated | 27 |
Inadequacy Of Device Shape And/or Size | 25 |
Disassembly | 22 |
Fitting Problem | 12 |
Mechanical Jam | 9 |
Off-Label Use | 9 |
Device Slipped | 8 |
Device Contamination With Chemical Or Other Material | 6 |
Material Deformation | 5 |
Device-Device Incompatibility | 4 |
Device Packaging Compromised | 4 |
Packaging Problem | 4 |
Difficult To Open Or Remove Packaging Material | 4 |
Scratched Material | 4 |
Delivered As Unsterile Product | 4 |
Material Twisted / Bent | 4 |
Difficult To Remove | 4 |
Osseointegration Problem | 3 |
Incorrect Measurement | 3 |
Metal Shedding Debris | 3 |
Device Disinfection Or Sterilization Issue | 3 |
Defective Device | 3 |
Crack | 3 |
Device Issue | 3 |
Unsealed Device Packaging | 3 |
Unintended Movement | 3 |
Device Contaminated During Manufacture Or Shipping | 3 |
Component Incompatible | 2 |
Material Separation | 2 |
Incomplete Or Missing Packaging | 2 |
Ambient Noise Problem | 2 |
Entrapment Of Device | 2 |
Difficult To Insert | 2 |
Component Missing | 2 |
Delamination | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Patient-Device Incompatibility | 2 |
Device Operates Differently Than Expected | 1 |
Failure To Osseointegrate | 1 |
Pitted | 1 |
Defective Component | 1 |
Corroded | 1 |
Misconnection | 1 |
Overfill | 1 |
Connection Problem | 1 |
Material Erosion | 1 |
Device Damaged Prior To Use | 1 |
Biocompatibility | 1 |
Positioning Problem | 1 |
Material Too Rigid Or Stiff | 1 |
Material Fragmentation | 1 |
Complete Blockage | 1 |
| Total Device Problems | 4986 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DePuy Orthopaedics, Inc. | II | Dec-03-2016 |
| 2 | DePuy Orthopaedics, Inc. | II | May-26-2015 |
| 3 | ZIMMER ORTHOPEDIC MFG LTD | II | Feb-21-2018 |
| 4 | Zimmer Biomet, Inc. | II | Mar-14-2018 |
| 5 | Zimmer Biomet, Inc. | II | Feb-22-2016 |