Definition: Intended As A Primary Joint Replacement Prosthesis In Total Hip Arthroplasty.
| Device Type ID | 4747 |
| Device Name | Prosthesis, Hip, Semi-constrained, Ceramic-on-metal Articulation |
| Physical State | Metal Femoral Stem, Ceramic Femoral Head, Metal Acetabular Liner Designed To Fit Within A Metal Acetaublar Shell |
| Technical Method | Comprised Of A Metal Liner Designed To Fit Within A Compatible Acetabular Shell Which Articulates With A Compatible Ceramic Femoral Head Attached To A Femoral Stem As Part Of A Primary Total Hip Joint Replacement System |
| Target Area | Hip Joint |
| 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 | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OVO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4747 |
| Device | Prosthesis, Hip, Semi-constrained, Ceramic-on-metal Articulation |
| Product Code | OVO |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Insufficient Information | 9 |
Device Dislodged Or Dislocated | 2 |
Appropriate Term/Code Not Available | 1 |
Material Disintegration | 1 |
Noise, Audible | 1 |
Separation Problem | 1 |
Naturally Worn | 1 |
Malposition Of Device | 1 |
Fitting Problem | 1 |
Loss Of Osseointegration | 1 |
| Total Device Problems | 19 |