MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-27 for CUSTOM CEMENT NOZZLE REDUCER N/A manufactured by Biomet Orthopedics.
[1662855]
It was reported that patient underwent a total hip arthroplasty utilizing a custom cement nozzle reducer for cement application on (b)(6), 2010. The cement nozzle reduce3 was incapsulated in the cement mantle during procedure and was retained by the patient.
Patient Sequence No: 1, Text Type: D, B5
[8762459]
Current information is insufficient to permit a conclusion as to the cause of the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2010-00394 |
| MDR Report Key | 1845529 |
| Report Source | 07 |
| Date Received | 2010-09-27 |
| Date of Report | 2010-08-30 |
| Date of Event | 2010-08-16 |
| Date Facility Aware | 2010-08-16 |
| Date Mfgr Received | 2010-08-30 |
| Device Manufacturer Date | 2010-08-04 |
| Date Added to Maude | 2010-09-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEREMY SCHROEDER |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743713755 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM CEMENT NOZZLE REDUCER |
| Generic Name | EVACUATOR, CEMENT MONOMER |
| Product Code | JDY |
| Date Received | 2010-09-27 |
| Model Number | N/A |
| Catalog Number | CUSTOM |
| Lot Number | RD29948 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2010-09-27 |