MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,07 report with the FDA on 2011-06-28 for VISIONAIRE GII FEMOR V0100010 manufactured by Smith & Nephew, Inc..
[18841390]
It was reported that the cutting blocks caused a larger than desired resectioning of the bone. Due to this, surgery time was extended between 30 and 60 minutes.
Patient Sequence No: 1, Text Type: D, B5
[19042143]
.
Patient Sequence No: 1, Text Type: N, H10
[21519091]
Review of shop order paperwork shows no issues. Dimensional investigation did not determine any characteristics that would contribute to the stated failure mode. Engineering investigation determined that a slight anterior osteophyte may have not been accounted for during segmentation. This would have pushed the block up and caused pinholes to be more anterior. This would in turn cause posterior and distal resections to be larger.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2011-00225 |
| MDR Report Key | 2142344 |
| Report Source | *,07 |
| Date Received | 2011-06-28 |
| Date of Report | 2011-06-28 |
| Date of Event | 2011-06-13 |
| Date Mfgr Received | 2011-06-13 |
| Device Manufacturer Date | 2011-06-03 |
| Date Added to Maude | 2011-06-28 |
| 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 | 0 |
| Manufacturer Contact | MR. JERRY HOWARD |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996153 |
| Manufacturer G1 | SMITH & NEPHEW, INC |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISIONAIRE GII FEMOR |
| Generic Name | VISIONAIRE DSTL FEM CUTTING BLOCK - GII |
| Product Code | IQO |
| Date Received | 2011-06-28 |
| Returned To Mfg | 2011-06-21 |
| Catalog Number | V0100010 |
| Lot Number | PM027513V1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-28 |