MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-02-26 for SAWBLADE/EKD manufactured by Smith & Nephew, Inc. Ag Orthopaedic Division.
[1284364]
It has been reported that surgery time was extended because the sawblades would not fit through the cutting blocks correctly. The surgeon elected to continue with the surgery, and once the surgical procedure was completed, the unicondylar knee components did not track correctly. At that time the surgeon elected to change from the unicondylar knee to a total knee.
Patient Sequence No: 1, Text Type: D, B5
[8449702]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613369-2010-00011 |
| MDR Report Key | 1618575 |
| Report Source | 01,07 |
| Date Received | 2010-02-26 |
| Date of Report | 2010-02-25 |
| Date of Event | 2010-01-29 |
| Date Mfgr Received | 2010-02-03 |
| Date Added to Maude | 2010-03-04 |
| 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 | SMITH & NEPHEW, INC. |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5000 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 5000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | SAWBLADE/EKD |
| Product Code | EKD |
| Date Received | 2010-02-26 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. AG ORTHOPAEDIC DIVISION |
| Manufacturer Address | AARAU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-02-26 |