MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-10-09 for VISIONAIRE V0100010 manufactured by Brooks Manufacturing Site.
[1240173]
It has been reported that additional surgery time was required, because the surgeon notched the femur approximately 2mm. The surgeon stopped the surgery and closed the patient. A total knee was completed the next day with a legion femoral component, and a 16 mm by 120 mm stem to bridge the area of concern of the notch to prevent a potential femoral notch induced fracture. The patient had to wait 23 hours in the hospital for completion of the total knee.
Patient Sequence No: 1, Text Type: D, B5
[8418801]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2009-00719 |
| MDR Report Key | 1503442 |
| Report Source | 07 |
| Date Received | 2009-10-09 |
| Date of Report | 2009-10-08 |
| Date of Event | 2009-09-09 |
| Date Mfgr Received | 2009-09-11 |
| Date Added to Maude | 2009-10-16 |
| 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 | MRS. LEAH EASLEY |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996137 |
| Manufacturer G1 | BROOKS MANUFACTURING SITE |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISIONAIRE |
| Generic Name | CUTTING BLOCK / IQO |
| Product Code | IQO |
| Date Received | 2009-10-09 |
| Model Number | NA |
| Catalog Number | V0100010 |
| Lot Number | PM001969V1 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BROOKS MANUFACTURING SITE |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-10-09 |