| Device Type ID | 4613 |
| Device Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish |
| Regulation Description | Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous 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 | 888.3353 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MAY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4613 |
| Device | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish |
| Product Code | MAY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis. |
| CFR Regulation Number | 888.3353 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 55 |
Fracture | 42 |
Material Integrity Problem | 22 |
Adverse Event Without Identified Device Or Use Problem | 21 |
Device Dislodged Or Dislocated | 21 |
Break | 15 |
Mechanical Problem | 9 |
Detachment Of Device Component | 9 |
Appropriate Term/Code Not Available | 8 |
Material Deformation | 6 |
Device Slipped | 6 |
Naturally Worn | 5 |
Handpiece | 5 |
Migration Or Expulsion Of Device | 4 |
Metal Shedding Debris | 4 |
Connection Problem | 4 |
Crack | 4 |
Loose Or Intermittent Connection | 4 |
Fitting Problem | 4 |
Device-Device Incompatibility | 3 |
Mechanical Jam | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Mechanics Altered | 3 |
Thread | 3 |
Detachment Of Device Or Device Component | 3 |
Device Operates Differently Than Expected | 3 |
Unstable | 3 |
Difficult To Remove | 2 |
Use Of Device Problem | 2 |
Noise, Audible | 2 |
Difficult To Insert | 2 |
Material Fragmentation | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Sticking | 1 |
Separation Failure | 1 |
Component Or Accessory Incompatibility | 1 |
Material Protrusion / Extrusion | 1 |
Clip | 1 |
Plate | 1 |
Positioning Problem | 1 |
Post | 1 |
Component Falling | 1 |
Disconnection | 1 |
Material Erosion | 1 |
Split | 1 |
Difficult To Position | 1 |
Screw | 1 |
Degraded | 1 |
Disassembly | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Shaft | 1 |
Difficult Or Delayed Positioning | 1 |
Device Contamination With Body Fluid | 1 |
Migration | 1 |
| Total Device Problems | 306 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Howmedica Osteonics Corp. | II | Feb-25-2016 |