| Device Type ID | 4581 |
| Device Name | Prosthesis, Hip, Femoral, Resurfacing |
| Regulation Description | Hip Joint Femoral (hemi-hip) Metallic Resurfacing Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KXA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4581 |
| Device | Prosthesis, Hip, Femoral, Resurfacing |
| Product Code | KXA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Femoral (hemi-hip) Metallic Resurfacing Prosthesis. |
| CFR Regulation Number | 888.3400 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 1586 |
Appropriate Term/Code Not Available | 710 |
Noise, Audible | 152 |
Metal Shedding Debris | 135 |
Adverse Event Without Identified Device Or Use Problem | 129 |
Loss Of Osseointegration | 128 |
Device Dislodged Or Dislocated | 124 |
Corroded | 71 |
Material Disintegration | 52 |
Naturally Worn | 29 |
Loose Or Intermittent Connection | 25 |
Fracture | 22 |
Malposition Of Device | 15 |
Material Erosion | 14 |
Migration Or Expulsion Of Device | 14 |
Loss Of Or Failure To Bond | 9 |
Break | 7 |
Biocompatibility | 4 |
Failure To Osseointegrate | 4 |
Osseointegration Problem | 4 |
Unstable | 3 |
Device Slipped | 3 |
Mechanical Problem | 2 |
Device Issue | 2 |
Connection Problem | 2 |
Delivered As Unsterile Product | 1 |
Disassembly | 1 |
Explanted | 1 |
No Apparent Adverse Event | 1 |
Material Integrity Problem | 1 |
Device Operates Differently Than Expected | 1 |
Bent | 1 |
Patient Device Interaction Problem | 1 |
Excess Flow Or Over-Infusion | 1 |
Detachment Of Device Component | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Socket | 1 |
Device Expiration Issue | 1 |
Microbial Contamination Of Device | 1 |
Packaging Problem | 1 |
Difficult To Insert | 1 |
Ambient Noise Problem | 1 |
| Total Device Problems | 3263 |