MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-21 for LEGION V0100020 manufactured by Smith & Nephewm, Inc. Orthopaedic Division.
[1429538]
It has been reported that surgery time was extended due to issues with making the anterior cuts during the surgery.
Patient Sequence No: 1, Text Type: D, B5
[1769539]
Customer reported that false negative reactions were observed with a patient sample that resulted as type o in the forward grouping but resulted as type a in the reverse grouping. Testing was repeated with the same results. Per internal policy, the sample was sent to the reference lab for confirmation using tube method. The reference lab reported the sample to be group o, with no issues. Daily qc was acceptable. All listed products have been stored as per package inserts and appear normal before use. All other samples tested have resulted without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2010-00267 |
| MDR Report Key | 1840040 |
| Report Source | 07 |
| Date Received | 2010-09-21 |
| Date of Report | 2010-10-07 |
| Date of Event | 2010-08-20 |
| Date Mfgr Received | 2010-08-24 |
| Date Added to Maude | 2010-10-07 |
| 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. JENNIFER NELMS |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995451 |
| Manufacturer G1 | SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION |
| Manufacturer Street | 1450 BROOKS RD. |
| 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 | LEGION |
| Generic Name | VISIONAIRE DSTL FEM CUTTING BLOCK |
| Product Code | EKD |
| Date Received | 2010-09-21 |
| Returned To Mfg | 2010-08-30 |
| Catalog Number | V0100020 |
| Lot Number | PM012139V1 |
| 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 & NEPHEWM, INC. ORTHOPAEDIC DIVISION |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-09-21 |