| Device Type ID | 4570 |
| Device Name | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4570 |
| Device | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Product Code | KWL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Femoral (hemi-hip) Metallic Cemented Or Uncemented Prosthesis. |
| CFR Regulation Number | 888.3360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OSTEOREMEDIES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTEOREMEDIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 400 |
Appropriate Term/Code Not Available | 150 |
Loss Of Osseointegration | 138 |
Adverse Event Without Identified Device Or Use Problem | 74 |
Device Dislodged Or Dislocated | 65 |
Corroded | 50 |
Migration Or Expulsion Of Device | 49 |
Fracture | 32 |
Break | 23 |
Detachment Of Device Component | 16 |
Fitting Problem | 15 |
Loose Or Intermittent Connection | 15 |
Osseointegration Problem | 14 |
Inadequacy Of Device Shape And/or Size | 13 |
Naturally Worn | 11 |
Loss Of Or Failure To Bond | 10 |
Malposition Of Device | 9 |
Biocompatibility | 9 |
Material Deformation | 9 |
Mechanical Problem | 8 |
Noise, Audible | 8 |
Metal Shedding Debris | 8 |
Degraded | 7 |
Migration | 6 |
Positioning Problem | 6 |
Material Erosion | 5 |
Difficult To Insert | 5 |
Device Operates Differently Than Expected | 5 |
Failure To Osseointegrate | 4 |
Material Integrity Problem | 4 |
Nonstandard Device | 4 |
Packaging Problem | 4 |
Device Slipped | 4 |
Defective Device | 3 |
Loosening Of Implant Not Related To Bone-Ingrowth | 3 |
Failure To Adhere Or Bond | 3 |
Material Discolored | 3 |
Unstable | 3 |
Material Twisted / Bent | 3 |
Difficult To Remove | 3 |
Material Disintegration | 3 |
Device-Device Incompatibility | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Scratched Material | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Device Disinfection Or Sterilization Issue | 1 |
Device Markings / Labelling Problem | 1 |
Stretched | 1 |
Difficult To Position | 1 |
Crack | 1 |
Device Expiration Issue | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Physical Resistance / Sticking | 1 |
Device Issue | 1 |
Device Packaging Compromised | 1 |
Patient Device Interaction Problem | 1 |
Cap | 1 |
Cups | 1 |
Defective Component | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Compatibility Problem | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Delivered As Unsterile Product | 1 |
Connection Problem | 1 |
| Total Device Problems | 1232 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DePuy Orthopaedics, Inc. | II | Oct-11-2018 |
| 2 | DePuy Orthopaedics, Inc. | II | Feb-12-2018 |
| 3 | Smith & Nephew, Inc. | II | Jan-05-2016 |