| Device Type ID | 4723 |
| Device Name | Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented |
| 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 | Contact ODE |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MJT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4723 |
| Device | Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented |
| Product Code | MJT |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Insufficient Information | 36 |
Device Dislodged Or Dislocated | 13 |
Migration Or Expulsion Of Device | 8 |
Fracture | 7 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Unstable | 5 |
Appropriate Term/Code Not Available | 4 |
Loose Or Intermittent Connection | 4 |
Naturally Worn | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Loss Of Osseointegration | 2 |
Mechanical Jam | 2 |
Loss Of Or Failure To Bond | 2 |
Unintended System Motion | 1 |
Difficult To Remove | 1 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
Separation Failure | 1 |
Detachment Of Device Component | 1 |
Defective Device | 1 |
Detachment Of Device Or Device Component | 1 |
Malposition Of Device | 1 |
Material Erosion | 1 |
Difficult To Insert | 1 |
| Total Device Problems | 104 |