| Device Type ID | 4618 |
| Device Name | Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous |
| Regulation Description | Hip Joint Metal/polymer/metal Semi-constrained Porous-coated Uncemented 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 | 888.3358 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MBL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4618 |
| Device | Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous |
| Product Code | MBL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Metal/polymer/metal Semi-constrained Porous-coated Uncemented Prosthesis. |
| CFR Regulation Number | 888.3358 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Insufficient Information | 84 |
Device Dislodged Or Dislocated | 39 |
Adverse Event Without Identified Device Or Use Problem | 32 |
Loose Or Intermittent Connection | 15 |
Unintended Movement | 12 |
Appropriate Term/Code Not Available | 7 |
Connection Problem | 5 |
Fracture | 5 |
Migration Or Expulsion Of Device | 3 |
Fitting Problem | 3 |
Mechanical Problem | 3 |
Device Slipped | 2 |
Break | 2 |
Malposition Of Device | 2 |
Difficult To Insert | 2 |
Unstable | 2 |
High Test Results | 2 |
No Apparent Adverse Event | 1 |
Degraded | 1 |
Metal Shedding Debris | 1 |
Osseointegration Problem | 1 |
Failure To Adhere Or Bond | 1 |
Corroded | 1 |
Misconnection | 1 |
Device Operates Differently Than Expected | 1 |
Positioning Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Naturally Worn | 1 |
Loss Of Osseointegration | 1 |
Device-Device Incompatibility | 1 |
Cover | 1 |
Detachment Of Device Component | 1 |
Leak / Splash | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
| Total Device Problems | 239 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | MicroPort Orthopedics, Inc. | I | Sep-28-2015 |
| 2 | Smith & Nephew Inc | II | Feb-21-2014 |