Definition: For Use As A Component Of A Total Hip Prosthesis In Primary And Revision Patients At High Risk Of Dislocation Due To A History Of Prior Dislocation, Bone Loss, Joint Or Soft Tissue Laxity, Neuromuscular Disease, Or Intraoperative Instability, And For
| Device Type ID | 4679 |
| Device Name | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive |
| Physical State | System Contains Acvetabular Screws, Acetabular Shell, Constrained UHMWPE Acetabular Liner Doped With An Additive, A Femoral Ball, And A Metallic Femoral Stem. |
| Technical Method | This Device Is Intended To Be Implanted To Replace A Hip Joint. The Device Limits Translation And Rotation In One Or More Planes Via The Geometry Of Its Articulating Surfaces. The Liner Constrains The Head Such That It Prevent Axial Dislocation. This |
| Target Area | Hip |
| Regulation Description | Hip Joint Metal/polymer Constrained 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 | 888.3310 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PBI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4679 |
| Device | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive |
| Product Code | PBI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Metal/polymer Constrained Cemented Or Uncemented Prosthesis. |
| CFR Regulation Number | 888.3310 [🔎] |
| Device Problems | |
|---|---|
Difficult To Insert | 225 |
Insufficient Information | 111 |
Fracture | 111 |
Difficult To Position | 60 |
Device Dislodged Or Dislocated | 57 |
Component Or Accessory Incompatibility | 47 |
Fitting Problem | 33 |
Device-Device Incompatibility | 26 |
Migration Or Expulsion Of Device | 25 |
Adverse Event Without Identified Device Or Use Problem | 23 |
Packaging Problem | 21 |
Device Contaminated During Manufacture Or Shipping | 13 |
Break | 12 |
Positioning Problem | 11 |
Device Packaging Compromised | 11 |
Separation Failure | 9 |
Difficult To Remove | 9 |
Tear, Rip Or Hole In Device Packaging | 7 |
Appropriate Term/Code Not Available | 7 |
Unsealed Device Packaging | 7 |
Detachment Of Device Or Device Component | 7 |
Difficult Or Delayed Positioning | 6 |
Malposition Of Device | 5 |
Material Deformation | 5 |
Noise, Audible | 4 |
Delivered As Unsterile Product | 4 |
Tip | 4 |
Disassembly | 4 |
Corroded | 4 |
Device Operates Differently Than Expected | 3 |
Difficult To Open Or Remove Packaging Material | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Accessory Incompatible | 3 |
Detachment Of Device Component | 2 |
Sticking | 2 |
Material Separation | 2 |
Defective Device | 2 |
Thread | 2 |
Device Markings / Labelling Problem | 2 |
Loose Or Intermittent Connection | 2 |
Device Damaged Prior To Use | 2 |
Disconnection | 2 |
Bent | 2 |
Unstable | 2 |
Metal Shedding Debris | 2 |
Misassembled | 2 |
Label | 1 |
Difficult To Open Or Close | 1 |
Degraded | 1 |
Material Discolored | 1 |
Misconnection | 1 |
Migration | 1 |
Problem With Sterilization | 1 |
Entrapment Of Device | 1 |
Component Falling | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Scratched Material | 1 |
Crack | 1 |
Filling Problem | 1 |
Mechanical Problem | 1 |
Installation-Related Problem | 1 |
Mechanical Jam | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
| Total Device Problems | 923 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | II | Jun-19-2014 |