| Device Type ID | 4523 |
| Device Name | Prosthesis, Hip, Femoral Component, Cemented, 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 | JDG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4523 |
| Device | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Product Code | JDG |
| 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 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER ORTHOPAEDICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 872 |
Appropriate Term/Code Not Available | 252 |
Device Dislodged Or Dislocated | 142 |
Adverse Event Without Identified Device Or Use Problem | 135 |
Loss Of Osseointegration | 73 |
Break | 72 |
Corroded | 58 |
Fracture | 55 |
Naturally Worn | 42 |
Noise, Audible | 41 |
Migration Or Expulsion Of Device | 38 |
Unstable | 37 |
Material Erosion | 37 |
Metal Shedding Debris | 32 |
Material Disintegration | 26 |
Malposition Of Device | 18 |
Degraded | 15 |
Loss Of Or Failure To Bond | 14 |
Material Deformation | 12 |
Migration | 11 |
Biocompatibility | 10 |
Mechanical Problem | 7 |
Loose Or Intermittent Connection | 6 |
Positioning Problem | 6 |
Failure To Adhere Or Bond | 6 |
Osseointegration Problem | 6 |
Material Integrity Problem | 5 |
Detachment Of Device Or Device Component | 5 |
Loosening Of Implant Not Related To Bone-Ingrowth | 5 |
Unintended Movement | 4 |
Difficult To Insert | 4 |
Device Handling Problem | 3 |
Compatibility Problem | 3 |
Patient-Device Incompatibility | 3 |
Disassembly | 2 |
Separation Failure | 2 |
Device Misassembled During Manufacturing / Shipping | 2 |
Flaked | 2 |
Nonstandard Device | 2 |
Crack | 2 |
Separation Problem | 1 |
Device Damaged Prior To Use | 1 |
Device Markings / Labelling Problem | 1 |
Material Distortion | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Detachment Of Device Component | 1 |
Peeled / Delaminated | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Fitting Problem | 1 |
Mechanical Jam | 1 |
Component Incompatible | 1 |
Use Of Device Problem | 1 |
Screw | 1 |
No Apparent Adverse Event | 1 |
Misassembled | 1 |
Connection Problem | 1 |
Material Twisted / Bent | 1 |
Cups | 1 |
Bent | 1 |
Difficult To Remove | 1 |
Failure To Osseointegrate | 1 |
Handpiece | 1 |
Defective Component | 1 |
Solder Joint Fracture | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Device Fell | 1 |
| Total Device Problems | 2093 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Zimmer, Inc. | II | Aug-26-2014 |
| 2 | Zimmer, Inc. | II | Aug-13-2014 |
| 3 | Zimmer, Inc. | II | Feb-20-2014 |