| Device Type ID | 4729 |
| Device Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| 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 | MRA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4729 |
| Device | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Product Code | MRA |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Break | 895 |
Insufficient Information | 319 |
Fracture | 196 |
Appropriate Term/Code Not Available | 95 |
Device Dislodged Or Dislocated | 87 |
Noise, Audible | 52 |
Crack | 46 |
Adverse Event Without Identified Device Or Use Problem | 46 |
Loss Of Osseointegration | 41 |
Migration Or Expulsion Of Device | 33 |
Naturally Worn | 30 |
Disassembly | 29 |
Malposition Of Device | 28 |
Loose Or Intermittent Connection | 23 |
Material Deformation | 16 |
Corroded | 14 |
Osseointegration Problem | 14 |
Unstable | 12 |
Loss Of Or Failure To Bond | 12 |
Metal Shedding Debris | 12 |
Difficult To Remove | 11 |
Material Integrity Problem | 10 |
Mechanical Problem | 10 |
Fitting Problem | 7 |
Inadequacy Of Device Shape And/or Size | 6 |
Failure To Adhere Or Bond | 6 |
Connection Problem | 6 |
Degraded | 5 |
Failure To Disconnect | 5 |
Device-Device Incompatibility | 4 |
Material Fragmentation | 4 |
Dull, Blunt | 3 |
Difficult To Insert | 3 |
Positioning Problem | 3 |
Scratched Material | 3 |
Device Inoperable | 3 |
Device Operates Differently Than Expected | 3 |
Bent | 2 |
Material Disintegration | 2 |
Material Erosion | 2 |
Detachment Of Device Or Device Component | 2 |
Mechanical Jam | 2 |
Peeled / Delaminated | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Unintended Movement | 2 |
No Pressure | 1 |
Detachment Of Device Component | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Dent In Material | 1 |
Plate | 1 |
Component Incompatible | 1 |
Material Separation | 1 |
Out-Of-Box Failure | 1 |
Device Issue | 1 |
Device Damaged By Another Device | 1 |
Difficult To Position | 1 |
Defective Device | 1 |
Thread | 1 |
Separation Problem | 1 |
Flaked | 1 |
Disconnection | 1 |
Device Damaged Prior To Use | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Material Distortion | 1 |
Material Twisted / Bent | 1 |
Failure To Osseointegrate | 1 |
Material Discolored | 1 |
Misconnection | 1 |
Unexpected Therapeutic Results | 1 |
Handpiece | 1 |
Migration | 1 |
Component Missing | 1 |
Incorrect Measurement | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Device Difficult To Setup Or Prepare | 1 |
Use Of Device Problem | 1 |
Tip | 1 |
| Total Device Problems | 2140 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Exactech, Inc. | II | Jun-02-2016 |
| 2 | Zimmer, Inc. | II | Feb-20-2014 |