| Device Type ID | 4615 |
| Device Name | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Regulation Description | Shoulder Joint Metal/polymer/metal Nonconstrained Or Semi-constrained Porous-coated 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 One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3670 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MBF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4615 |
| Device | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Product Code | MBF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Shoulder Joint Metal/polymer/metal Nonconstrained Or Semi-constrained Porous-coated Uncemented Prosthesis. |
| CFR Regulation Number | 888.3670 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FOURNITURES HOSPITALIERES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FOURNITURES HOSPITALIERES INDUSTRIE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIMACORPORATE S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 152 |
Unstable | 88 |
Adverse Event Without Identified Device Or Use Problem | 59 |
Migration Or Expulsion Of Device | 28 |
Device Dislodged Or Dislocated | 23 |
Appropriate Term/Code Not Available | 12 |
Packaging Problem | 12 |
Noise, Audible | 11 |
Inadequacy Of Device Shape And/or Size | 8 |
Detachment Of Device Component | 7 |
Malposition Of Device | 7 |
Detachment Of Device Or Device Component | 6 |
Mechanical Problem | 4 |
Difficult To Remove | 4 |
Migration | 4 |
Improper Or Incorrect Procedure Or Method | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Difficult To Insert | 3 |
Device Markings / Labelling Problem | 2 |
Material Erosion | 2 |
Defective Device | 2 |
Loss Of Osseointegration | 2 |
Device-Device Incompatibility | 2 |
Device Packaging Compromised | 2 |
Fracture | 2 |
Component Missing | 2 |
Disassembly | 1 |
Incorrect Measurement | 1 |
Material Disintegration | 1 |
Material Twisted / Bent | 1 |
Failure To Adhere Or Bond | 1 |
Corroded | 1 |
Mechanical Jam | 1 |
Positioning Failure | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Separation Failure | 1 |
Device Damaged By Another Device | 1 |
Difficult To Position | 1 |
Naturally Worn | 1 |
Disconnection | 1 |
Positioning Problem | 1 |
Scratched Material | 1 |
| Total Device Problems | 467 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | III | Jun-11-2015 |
| 2 | Zimmer Biomet, Inc. | II | Dec-07-2018 |
| 3 | Zimmer Biomet, Inc. | II | Dec-29-2017 |