Definition: Total Shoulders Are Indicated For Arthritis (osteo-, Rheumatoid, Traumatic), Avascular Necrosis, Correction Of Functional Deformity, And Revision Procedures.
| Device Type ID | 4677 |
| Device Name | Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented |
| Physical State | May Include: Humeral Stem Humeral Neck Humeral Tray Glenoid Component Glenoid Tray Glenosphere Fixation Screws Instrumentation |
| Technical Method | To Be Implanted To Replace A Shoulder Joint. It Limits Translation And Rotation In One Or More Planes Via The Geometry Of Its Articulating Surfaces. It Has No Linkage Across The Joint. This Generic Type Of Device Includes Prosthesis That Have A Muher |
| Target Area | Shoulder |
| Regulation Description | Shoulder Joint Metal/polymer Semi-constrained 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 One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PAO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4677 |
| Device | Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented |
| Product Code | PAO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Shoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3660 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 99 |
Fracture | 60 |
Device Dislodged Or Dislocated | 53 |
Difficult To Insert | 38 |
Unstable | 25 |
Migration Or Expulsion Of Device | 20 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Detachment Of Device Component | 10 |
Difficult To Position | 9 |
Device-Device Incompatibility | 8 |
Fitting Problem | 7 |
Naturally Worn | 7 |
Malposition Of Device | 5 |
Material Erosion | 5 |
Device Damaged By Another Device | 5 |
Disassembly | 5 |
Bent | 4 |
Mechanical Problem | 4 |
Noise, Audible | 4 |
Packaging Problem | 3 |
Appropriate Term/Code Not Available | 3 |
Metal Shedding Debris | 2 |
Difficult Or Delayed Positioning | 2 |
Patient-Device Incompatibility | 2 |
Device Operates Differently Than Expected | 2 |
Detachment Of Device Or Device Component | 2 |
Break | 2 |
Component Or Accessory Incompatibility | 2 |
Off-Label Use | 2 |
Material Separation | 1 |
Incomplete Or Missing Packaging | 1 |
Separation Failure | 1 |
Plate | 1 |
Unsealed Device Packaging | 1 |
Material Deformation | 1 |
Adapter (Adaptor) | 1 |
Failure To Align | 1 |
Scratched Material | 1 |
Device Damaged Prior To Use | 1 |
Device Operational Issue | 1 |
Defective Component | 1 |
Compatibility Problem | 1 |
Failure To Adhere Or Bond | 1 |
Misassembled | 1 |
Delivered As Unsterile Product | 1 |
Screw | 1 |
| Total Device Problems | 421 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Zimmer Biomet, Inc. | I | Feb-11-2017 |