| Device Type ID | 4614 |
| Device Name | Bone Cement, Antibiotic |
| Regulation Description | Polymethylmethacrylate (PMMA) Bone Cement. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3027 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MBB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4614 |
| Device | Bone Cement, Antibiotic |
| Product Code | MBB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polymethylmethacrylate (PMMA) Bone Cement. |
| CFR Regulation Number | 888.3027 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ZIMMER BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Unsealed Device Packaging | 435 |
Infusion Or Flow Problem | 317 |
No Flow | 54 |
Improper Chemical Reaction | 52 |
Insufficient Information | 51 |
Loss Of Or Failure To Bond | 27 |
Appropriate Term/Code Not Available | 24 |
Device Packaging Compromised | 18 |
Tear, Rip Or Hole In Device Packaging | 14 |
Failure To Adhere Or Bond | 12 |
Leak / Splash | 11 |
Packaging Problem | 11 |
Migration Or Expulsion Of Device | 9 |
Device Operates Differently Than Expected | 8 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Missing Value Reason | 6 |
Loss Of Osseointegration | 6 |
Incomplete Or Missing Packaging | 5 |
Chemical Problem | 5 |
Physical Property Issue | 5 |
Clumping In Device Or Device Ingredient | 5 |
Loosening Of Implant Not Related To Bone-Ingrowth | 4 |
Improper Flow Or Infusion | 4 |
Break | 4 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Device Handling Problem | 3 |
Contamination During Use | 3 |
Material Integrity Problem | 3 |
Shipping Damage Or Problem | 3 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 2 |
Device Dislodged Or Dislocated | 2 |
Failure To Advance | 2 |
Precipitate In Device Or Device Ingredient | 2 |
Fracture | 2 |
Device Disinfection Or Sterilization Issue | 2 |
Temperature Problem | 2 |
Torn Material | 1 |
Naturally Worn | 1 |
Crack | 1 |
Device Expiration Issue | 1 |
Mechanical Problem | 1 |
Overheating Of Device | 1 |
Shelf Life Exceeded | 1 |
Device Slipped | 1 |
Defective Device | 1 |
Device Damaged Prior To Use | 1 |
Malposition Of Device | 1 |
Human Factors Issue | 1 |
Device Emits Odor | 1 |
Inadequate Or Insufficient Training | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Physical Resistance / Sticking | 1 |
Sticking | 1 |
Detachment Of Device Component | 1 |
Fire | 1 |
Product Quality Problem | 1 |
Unstable | 1 |
Defective Component | 1 |
Use Of Device Problem | 1 |
Difficult To Open Or Close | 1 |
Delivered As Unsterile Product | 1 |
| Total Device Problems | 1150 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DePuy Orthopaedics, Inc. | II | Mar-05-2015 |
| 2 | Zimmer, Inc. | II | Jan-13-2014 |