| Device Type ID | 4600 |
| Device Name | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Regulation Description | Hip Joint Femoral (hemi-hip) Metallic Cemented Or 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 | 888.3360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LWJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4600 |
| Device | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Product Code | LWJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Femoral (hemi-hip) Metallic Cemented Or Uncemented Prosthesis. |
| CFR Regulation Number | 888.3360 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 262 |
Break | 226 |
Device Dislodged Or Dislocated | 91 |
Fracture | 68 |
Loose Or Intermittent Connection | 55 |
Corroded | 48 |
Loss Of Osseointegration | 41 |
Dull, Blunt | 35 |
Appropriate Term/Code Not Available | 33 |
Naturally Worn | 25 |
Adverse Event Without Identified Device Or Use Problem | 21 |
Migration Or Expulsion Of Device | 21 |
Metal Shedding Debris | 20 |
Unstable | 10 |
Material Integrity Problem | 9 |
Failure To Adhere Or Bond | 7 |
Device Operates Differently Than Expected | 7 |
Device Slipped | 6 |
Noise, Audible | 5 |
Malposition Of Device | 5 |
Osseointegration Problem | 5 |
Degraded | 5 |
Material Deformation | 4 |
Device Contamination With Chemical Or Other Material | 3 |
Detachment Of Device Component | 3 |
Positioning Problem | 3 |
Disassembly | 3 |
Material Discolored | 3 |
Compatibility Problem | 2 |
Difficult To Remove | 2 |
Component Missing | 2 |
Loss Of Or Failure To Bond | 2 |
Fitting Problem | 2 |
Material Fragmentation | 2 |
Material Too Rigid Or Stiff | 1 |
Material Separation | 1 |
Device Issue | 1 |
Device Damaged By Another Device | 1 |
Loosening Of Implant Not Related To Bone-Ingrowth | 1 |
Component Incompatible | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Accessory Incompatible | 1 |
Battery Charger, Defective | 1 |
Device Subassembly | 1 |
Scratched Material | 1 |
Material Distortion | 1 |
Packaging Problem | 1 |
Collapse | 1 |
Device Expiration Issue | 1 |
Mechanical Problem | 1 |
No Apparent Adverse Event | 1 |
Device Difficult To Setup Or Prepare | 1 |
Use Of Device Problem | 1 |
Biofilm Coating In Device | 1 |
Material Disintegration | 1 |
Device Appears To Trigger Rejection | 1 |
| Total Device Problems | 1058 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | MicroPort Orthopedics Inc. | II | Aug-18-2016 |
| 2 | Zimmer, Inc. | II | Feb-20-2014 |