Definition: Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing Device Relieves Hip Pain And Improves Hip Function By Replacing The Parts Of The Hip That Have Been Severely Damaged By Degenerative Joint Diseases. This Device Is Indicated For Patients Wit
| Device Type ID | 4742 |
| Device Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Physical State | The Femoral Resurfacing Component And Acetabular Components Are Made Of Metal. These Surfaces Rub Against Each Other (the Bearing Couple) And Are Made From Highly-polished Metal. This Type Of Bearing Couple Is Called A Metal-on-metal Bearing Couple. |
| Technical Method | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing Device Has Two Parts: A Socket In The Shape Of A Shallow Cup (acetabular Component), And A Cap In The Form Of A Ball Head (femoral Resurfacing Component). The Cup Replaces The Damaged Surfac |
| Target Area | The Device Is To Replace The 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 | NXT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4742 |
| Device | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Product Code | NXT |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 333 |
Insufficient Information | 221 |
Adverse Event Without Identified Device Or Use Problem | 208 |
Metal Shedding Debris | 31 |
Patient Device Interaction Problem | 24 |
Device Operates Differently Than Expected | 16 |
Unintended Movement | 11 |
Material Integrity Problem | 10 |
Noise, Audible | 9 |
Device Dislodged Or Dislocated | 7 |
Fracture | 6 |
Break | 6 |
Loose Or Intermittent Connection | 6 |
Patient-Device Incompatibility | 5 |
Mechanical Problem | 4 |
Device Slipped | 4 |
Detachment Of Device Or Device Component | 3 |
Naturally Worn | 3 |
Malposition Of Device | 2 |
Loss Of Osseointegration | 2 |
Migration Or Expulsion Of Device | 2 |
Connection Problem | 2 |
Cannula | 1 |
Difficult Or Delayed Positioning | 1 |
High Test Results | 1 |
No Apparent Adverse Event | 1 |
Failure To Cut | 1 |
Screw | 1 |
Degraded | 1 |
Premature Explantation | 1 |
Use Of Device Problem | 1 |
Difficult To Remove | 1 |
Cups | 1 |
Bent | 1 |
Osseointegration Problem | 1 |
Unstable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Compatibility Problem | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Device-Device Incompatibility | 1 |
Sticking | 1 |
Fitting Problem | 1 |
Device Issue | 1 |
Positioning Problem | 1 |
Insufficient Flow Or Under Infusion | 1 |
Material Erosion | 1 |
No Fail-Safe Mechanism | 1 |
Failure To Align | 1 |
Premature System Activation | 1 |
Collapse | 1 |
Crack | 1 |
| Total Device Problems | 944 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Smith & Nephew, Inc. | II | May-21-2018 |
| 2 | Smith & Nephew, Inc. | II | Sep-10-2015 |