MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-04 for ITOTAL G2 M57250600010 manufactured by Conformis, Inc..
[25691989]
It was reported that the ijig instruments were wet when removed from the sterile packaging during surgery. No moisture was observed on implant components. The or staff re-sterilized the ijigs. Surgery was completed successfully. Investigation conducted using kits in finished goods inventory indicates that ijig instrumentation may contain small amounts of ethylene glycol residue. Conformis has initiated a voluntary recall.
Patient Sequence No: 1, Text Type: N, H10
[25691990]
It was reported that the ijig instruments were wet when removed from the sterile packaging during surgery. No moisture was observed on implant components. The operating room staff re-sterilized the ijigs. Surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011705391-2015-00170 |
| MDR Report Key | 5057520 |
| Date Received | 2015-09-04 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-08-24 |
| Date Mfgr Received | 2015-08-24 |
| Device Manufacturer Date | 2015-08-17 |
| Date Added to Maude | 2015-09-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARINA SNOW |
| Manufacturer Street | 28 CROSBY DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7813459195 |
| Manufacturer G1 | CONFORMIS, INC. |
| Manufacturer Street | 600 RESEARCH DRIVE |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3009844603-8/30/15-001-R |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ITOTAL G2 |
| Generic Name | TOTAL KNEE REPLACEMENT SYSTEM |
| Product Code | OOG |
| Date Received | 2015-09-04 |
| Catalog Number | M57250600010 |
| Device Expiration Date | 2016-01-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONFORMIS, INC. |
| Manufacturer Address | 28 CROSBY DRIVE BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-04 |