MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-12-09 for ULTRA-DRIVE III CONSOLE N/A 423935 manufactured by Biomet.
[2463531]
It was reported during an ultra drive cement removal procedure, the ultra drive iii console had an alleged malfunction and would not work. Other instrumentation was used to complete the procedure but only after a delay of greater than 30 minutes had occurred.
Patient Sequence No: 1, Text Type: D, B5
[9568526]
Supplier received the product for functional evaluation. Supplier evaluation found that the device functioned as intended. The user facility was notified of the event on (b)(6) 2011. To date, a response has not been received from the user facility. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda. Supplier received the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2011-01117 |
| MDR Report Key | 2364756 |
| Report Source | 05,07 |
| Date Received | 2011-12-09 |
| Date of Report | 2011-11-15 |
| Date of Event | 2011-10-10 |
| Date Mfgr Received | 2011-11-15 |
| Date Added to Maude | 2011-12-09 |
| 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 | 0 |
| Manufacturer Contact | MR. CRAIG BUCHMAN |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5743711132 |
| Manufacturer G1 | BIOMET |
| Manufacturer Street | 65 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA-DRIVE III CONSOLE |
| Generic Name | ULTRA-DRIVE III CONSOLE |
| Product Code | JXE |
| Date Received | 2011-12-09 |
| Model Number | N/A |
| Catalog Number | 423935 |
| Lot Number | 25105 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET |
| Manufacturer Address | 56 EAST BELL DRIVE WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-12-09 |