Definition: Call For PMAs 12/26/96 (61 FR 50710 (9/27/96))
| Device Type ID | 4561 |
| Device Name | Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal |
| Regulation Description | Hip Joint (hemi-hip) Acetabular Metal Cemented 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 | PMA |
| CFR Regulation Number | 888.3370 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KWB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4561 |
| Device | Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal |
| Product Code | KWB |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Hip Joint (hemi-hip) Acetabular Metal Cemented Prosthesis. |
| CFR Regulation Number | 888.3370 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 11 |
Device Dislodged Or Dislocated | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Fracture | 2 |
Loss Of Osseointegration | 2 |
Unintended Movement | 1 |
Coil | 1 |
Fitting Problem | 1 |
Break | 1 |
Mechanical Problem | 1 |
Naturally Worn | 1 |
Material Erosion | 1 |
Migration Or Expulsion Of Device | 1 |
Unstable | 1 |
Material Integrity Problem | 1 |
Unraveled Material | 1 |
Appropriate Term/Code Not Available | 1 |
Loss Of Or Failure To Bond | 1 |
Degraded | 1 |
| Total Device Problems | 34 |